Updated on 2024/12/18

Information

 

写真a

 
TODAKA KOJI
 
Organization
Kyushu University Hospital Center for Clinical and Translational Research Information Counter Professor
Data-Driven Innovation Initiative (Concurrent)
Kyushu University Hospital Center for Clinical and Translational Research Information Counter(Concurrent)
Academic Research and Industrial Collaboration Management Office of Kyushu University (Concurrent)
Center for Advanced Medical Open Innovation (Concurrent)
School of Medicine Department of Medicine(Concurrent)
Title
Professor
Profile
Translational research in various areas including cardiology which is his subspeciality implementation of ARO infrastructure as a vice director of CCTR to support TR, development of technology seeds arisen from Kyushu University research and human resource development in the regulatory science field
Homepage
External link

Research Areas

  • Life Science / Pharmaceutical chemistry and drug development sciences

Degree

  • Doctor of Medical Science

Research History

  • 国立循環器病センター心臓血管内科 厚生労働省 国立医薬品食品衛生研究所 医薬品医療機器審査センター 独立行政法人 医薬品医療機器総合機構   

    国立循環器病センター心臓血管内科 厚生労働省 国立医薬品食品衛生研究所 医薬品医療機器審査センター 独立行政法人 医薬品医療機器総合機構

  • International University of Health and Welfare   

Research Interests・Research Keywords

  • Research theme: Establishing a decentralized clinical trial infrastructure with a standardized electronic worksheet as its core, from both systems and an operational perspective.

    Keyword: drug discovery research, regulatory science

    Research period: 2022.6

  • Research theme: Research on resource dimension reduction and visualization of ARO function supported by seeds development results

    Keyword: drug discovery research, regulatory science, medical sociology, health-care economy

    Research period: 2020.4 - 2021.3

  • Research theme: Survey research for classification of ARO functions and creation of evaluation index by means of positioning analysis and heuristic methods

    Keyword: regulatory science, positioning analysis, multiple indicator analysis

    Research period: 2018.10 - 2020.3

  • Research theme: efficacy and safety evaluation method development for innovative therapeutic medical devices of cardiology

    Keyword: regulatory science, risk matrix, text mining

    Research period: 2012.10 - 2017.3

  • Research theme: International comparison of potential factors affecting medical technology acceptance by general public through risk-benefit perception

    Keyword: risk perception, device lag, drug lag, zero risk, regulatory science

    Research period: 2011.12 - 2013.3

  • Research theme: The double-blind comparative study on the efficacy of statin administration before coronary angioplasty in Japanese

    Keyword: statin, PCI, double blind

    Research period: 2006.10 - 2010.8

  • Research theme: Impact of cardiac rehabilitation on ventricular diastolic function

    Keyword: diastolic dysfunction, exercise training

    Research period: 2006.10 - 2009.3

  • Research theme: Basic Research of cardiac function by pressure-volume relationship

    Keyword: pressure-volume relationship, end-systolic elastance

    Research period: 1993.1 - 1997.1

Awards

  • 第4回レギュラトリーサイエンス学会学術大会優秀発表

    2014.9   レギュラトリーサイエンス学会   医療機器安全性評価へのリスク・マトリックス応用

  • Fellowship award

    1994.9   American Heart Association  

Papers

  • A Multicenter, Single-Blind, Randomized, Warfarin-Controlled Trial of Edoxaban in Patients With Chronic Thromboembolic Pulmonary Hypertension: KABUKI Trial. Reviewed International journal

    Hosokawa K, Watanabe H, Taniguchi Y, Ikeda N, Inami T, Yasuda S, Murohara T, Hatano M, Tamura Y, Yamashita J, Tatsumi K, Tsujino I, Kobayakawa Y, Adachi S, Yaoita N, Minatsuki S, Todaka K, Fukuda K, Tsutsui H, Abe K

    Circulation   2023.11

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    DOI: 10.1161/CIRCULATIONAHA.123.067528.

  • A novel quantitative indicator for disease progression rate in amyotrophic lateral sclerosis Reviewed International journal

    Yuko Kobayakawa, Koji Todaka, Yu Hashimoto, Senri Ko, Wataru Shiraishi, Junji Kishimoto, Jun ichi Kira, Ryo Yamasaki, Noriko Isobe

    Journal of the Neurological Sciences   442   120389   2022.11   ISSN:0022-510X eISSN:1878-5883

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    Objective: The current study sought to develop a new indicator for disease progression rate in amyotrophic lateral sclerosis (ALS). Methods: We used a nonparametric method to score diverse patterns of decline in the percentage of predicted forced vital capacity (%FVC) in patients with ALS. This involved 6317 longitudinal %FVC data sets from 920 patients in the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database volunteered by PRO-ACT Consortium members. To assess the utility of the derived scores as a disease indicator, we examined changes over time, the association with prognosis, and correlation with the Risk Profile of the Treatment Research Initiative to Cure ALS (TRICALS). Our local cohort (n = 92) was used for external validation. Results: We derived scores ranging from 35 to 106 points to construct the FVC Decline Pattern scale (FVC-DiP). Individuals' FVC-DiP scores were determined from a single measurement of %FVC and disease duration at assessment. Although the %FVC declined over the disease course (p < 0.0001), the FVC-DiP remained relatively stable. Low FVC-DiP scores were associated with rapid disease progression. Using our cohort, we demonstrated an association between FVC-DiP and the survival prognosis, the stability of the FVC-DiP per individual, and a correlation between FVC-DiP scores and the TRICALS Risk Profile (r2 = 0.904, p < 0.0001). Conclusions: FVC-DiP scores reflected patterns of declining %FVC over the natural course of ALS and indicated the disease progression rate. The FVC-DiP may enable easy assessment of disease progression patterns and could be used for assessing treatment efficacy.

    DOI: 10.1016/j.jns.2022.120389

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  • Impact of Risk-Benefit Perception and Trust on Medical Technology Acceptance in Relation to Drug and Device Lag: A Tripartite Cross-Sectional Survey Reviewed International journal

    戸高 浩司, Junji Kishimoto, Masayuki Ikeda, Koji Ikeda, Haruko Yamamoto

    Therapeutic Innovation & Regulatory Science   52 ( 5 )   629 - 640   2018.9

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    Background: New drug and medical device introduction in Japan usually lags behind that in the West. Many reports indicate that in Japan, the associated risks are considered greater than the benefits recognized in other countries. This study aimed to compare the relationship between risk-benefit perception and acceptance of medical technologies in 3 leading markets. Methods: A tri- partite cross-sectional survey of the general public was used. In total, 3345 adults in the United Kingdom, the United States, and Japan participated, and sexes and age groups were equally represented. Questions about the perception of risk, benefit, and acceptance of medical and other scientific technologies, and trust of medical product providers or regulatory authorities were included. Results: Five-step Likert coding for risk/benefit/acceptance of 4 medical items (x-rays, antibiotics, vaccines, and cardiac pacemakers) and 6 general items (such as automobiles and airplanes) were collected. Relationships between benefit perception and acceptance were linear for 4 medical technologies. The relationship had a similar slope but was shifted downward in Japan compared with the UK and US (P < .01), suggesting a lower acceptance in Japan for all benefit perceptions. The trend was the same between risk perception and acceptance, except for slopes that were negative. Correspondence analysis showed a strong correlation among acceptance of medical technologies, benefits of medical technologies, trust in doctors, and trust in the Department of Health. The UK and US attributes were clustered with positive responses such as “useful,” “acceptable,” and “trustworthy,” whereas Japan was clustered with intermediate to negative responses such as “neither” and “untrustworthy.” Conclusions: Acceptance of medical technologies was low in Japan because of significant differences in trust for doctors and authorities compared with that in the UK and US. This is a possible basis for delays of 24 to 60 months for medical product approval in Japan.

    DOI: 10.1177/2168479017739267

    Other Link: http://journals.sagepub.com/doi/full/10.1177/2168479017739267

  • Safety, Tolerability, and Preliminary Efficacy of the Anti-Fibrotic Small Molecule PRI-724, a CBP/β-Catenin Inhibitor, in Patients with Hepatitis C Virus-related Cirrhosis: A Single-Center, Open-Label, Dose Escalation Phase 1 Trial. Reviewed International journal

    木村 公則, 戸高 浩司, Nakanishi Y

    EBioMedicine   23   79 - 87   2017.9

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    BACKGROUND:

    There is currently no anti-fibrotic drug therapy available to treat hepatitis C virus (HCV) cirrhosis. The aim of this study was to assess the safety, tolerability, and anti-fibrotic effect of PRI-724, a small-molecule modulator of Wnt signaling, in patients with HCV cirrhosis.
    METHODS:

    In this single-center, open-label, phase 1 trial, we sequentially enrolled patients with HCV cirrhosis who were classified as Child-Pugh (CP) class A or B. PRI-724 was administered as a continuous intravenous infusion of 10, 40, or 160mg/m2/day for six cycles of 1week on and 1week off. The primary endpoints were frequency and severity of adverse events. The secondary endpoint was efficacy of PRI-724 in treating cirrhosis based on CP score and liver biopsy. This study is registered with ClinicalTrials.gov (no. NCT02195440).
    FINDINGS:

    Between Sept 3, 2014 and May 2, 2016, 14 patients were enrolled: CP class A:B, 6:8; median age, 62 (range: 43 to 74) years; male:female, 10:4. Twelve of the 14 patients completed six cycles of treatment; one was withdrawn from the study due to possible study drug-related liver injury (grade 3) in the 160mg/m2/day dose cohort and one withdrew for personal reasons. Serious adverse events occurred in three patients [21% (3/14)], one of which was possibly related to PRI-724. The most common adverse events were nausea [29% (4/14)] and fatigue [21% (3/14)]. After PRI-724 administration, the CP scores worsened by 1 point in two patients in the 10mg/m2/day cohort, improved in three patients at 1, 1, and 2 points in the 40mg/m2/day cohort, and improved in one patient by 3 points in the 160mg/m2/day cohort. The histology activity index scores of the liver tissue improved in two patients and exacerbated in two patients in the 10mg/m2/day cohort, and improved in one patient in the 40mg/m2/day cohort.
    INTERPRETATION:

    This study showed that administration of 10 or 40mg/m2/day intravenous PRI-724 over 12weeks was well-tolerated by patients with HCV cirrhosis; however, liver injury as a possible related serious adverse event was observed in the 160mg/m2/day cohort.
    FUNDING SOURCE:

    AMED.

    DOI: 10.1016/j.ebiom.2017.08.016

  • The challenge of magnetic vagal nerve stimulation for myocardial infarction -preliminary clinical trial. Reviewed International journal

    西川 拓也, 朔 啓太, 戸高 浩司, Hiroyuki Tsutsui, Sunagawa K

    Conf Proc IEEE Eng Med Biol Soc.   2017   4321 - 4324   2017.7

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    Numerous studies have shown in animal models that vagal nerve stimulation (VNS) strikingly reduces infarct size of acute myocardial infarction (AMI) and prevents heart failure. However, the lack of techniques to noninvasively stimulate the vagal nerve hinders VNS from clinical applications. Transcranial magnetic stimulation is noninvasive and capable of stimulating central neurons in patients. In this study, we examined whether the magnetic stimulation could noninvasively activate the cervical vagal nerve in healthy human. Sixteen healthy males and 4 females were enrolled in this study. We used Magstim Rapid2 with a 70-mm double coil in the right neck. We randomly assigned the subjects to 5 Hz or 20 Hz stimulation. We defined the maximum intensity of stimulation (MAX) which is the intensity just below the threshold of adverse effects. We defined HALF as a half of MAX. Protocols comprised 2 sets of MAX and 2 sets of HALF. Each stimulation continued for 3 minutes. We monitored heart rate (HR) and assessed the bradycardic response as an index of successful VNS. Nineteen subjects completed all protocols. They had no problematic adverse events during and/or after magnetic VNS. The magnetic VNS induced transient bradycardic responses in some subjects, whereas failed to induce sustained bradycardia in pooled data in any settings. Arterial pressure did not change either. Successful magnetic stimulation requires technical improvements including narrowing the magnetic focus and optimization of stimulation site. These improvements may enable us to apply magnetic VNS in the management of AMI.

    DOI: 10.1109/EMBC.2017.8037812

  • Ezetimibe in Combination with Statins Ameliorates Endothelial Dysfunction in Coronary Arteries after Stenting: The CuVIC Trial, a Multicenter Randomized Controlled Trial Reviewed International journal

    Takase S, Tetsuya Matoba, Nakashiro S, Yasushi Mukai, Inoue S, Keiji Oi, Taiki Higo, Katsuki S, Takemoto M, Suematsu N, Eshima K, Miyata K, Yamamoto M, Usui M, Sadamatsu K, Satoh S, Kadokami T, Hironaga K, 戸高 浩司

    Arterioscler Thromb Vasc Biol.   37 ( 2 )   350 - 358   2017.2

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  • 臨床研究と開発:Academic Research Organizationの役割

    戸高 浩司

    日本外科学会雑誌   117 ( 3 )   233 - 235   2016.5

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  • Global Cardiovascular Device Innovation: Japan-USA Synergies. Reviewed

    Uchida T, Ikeno F, Ikeda K, Suzuki Y, 戸高 浩司, Yokoi H, Thompson G, Krucoff M, Saito S

    Circ J   77   1714 - 1718   2013.7

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    Background: Global medical devices have become more popular, but investment money for medical device development is not easily available in the market. Worldwide health-care budget constraints mean that efficient medical device development has become essential. To achieve efficient development, globalization is a key to success. Spending large amounts of money in different regions for medical device development is no longer feasible. Methods and Results: In order to streamline processes of global medical device development, an academic, governmental, and industrial consortium, called the Harmonization by Doing program, has been set up. The program has been operating between Japan and the USA since 2003. The program has 4 working groups: (1) Global Cardiovascular Device Trials; (2) Study on Post-Market Registry; (3) Clinical Trials; and (4) Infrastructure and Methodology Regulatory Convergence and Communication. Each working group has as its goals the achievement of speedy and efficient medical device development in Japan and the USA. The program has held multiple international meetings to deal with obstacles against efficient medical device development. Conclusions: This kind of program is very important to deliver novel medical devices. Involvement of physicians in this type of activity is also very helpful to achieve these goals.

  • 予測予防対応型の医薬品安全監視計画 Invited

    佐瀬一洋、米本直裕、戸高浩司

    Jpn Pharmacol Ther(薬理と治療)   2005.1

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  • Load dependence of ventricular performance explained by model of calcium-myofilament interactions Reviewed International journal

    Shimizu J, Todaka K, Burkhoff D

    American Journal of Physiology   2002.3

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  • Effect of BAY y 5959 on myocardial function and metabolism in normal and failing hearts. Reviewed International journal

    Todaka K, Wang J, Yi GH, Gu A, Zhu SM, Zhang H, Burkhoff D

    American Journal of Physiology   1998.5

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  • Effect of ventricular stretch on contractile strength, calcium transient, and cAMP in intact canine hearts Reviewed International journal

    Todaka K, Ogino K, Gu A, Burkhoff D

    American Journal of Physiology   274 ( 3 )   H990 - H1000   1998.3

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  • Left-to-right systolic and diastolic ventricular interactions are dependent on right ventricular volume. Reviewed International journal

    Dickstein ML, Todaka K, Burkhoff D

    American Journal of Physiology   1997.6

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  • Impact of exercise training on ventricular properties in a canine model of congestive heart failure. Reviewed International journal

    Todaka K, Wang J, Yi GH, Knecht M, Stennett R, Packer M, Burkhoff D

    American Journal of Physiology   1997.3

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  • Characterizing ventricular mechanics and energetics following repeated coronary microembolization. Reviewed International journal

    Todaka K, Leibowitz D, Homma S, Fisher PE, DeRosa C, Stennett R, Packer M, Burkhoff D

    American Journal of Physiology   1997.1

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  • Safety and efficacy of ripasudil eye drops in preterm infants with retinopathy of prematurity: phase 1/2, open label, single-arm trial.

    Mitsuru Arima, Hirosuke Inoue, Akiko Misumi, Shoko Tsukamoto, Itsuka Matsushita, Shunsuke Araki, Manami Ohta, Kazumasa Takahashi, Miyuki Imazato, Tomoko Goto, Yoshinori Aoki, Koshiro Tagawa, Masayuki Hirose, Yuito Fujita, Noriko Yoshida, Shintaro Nakao, Hiroyuki Kondo, Koichi Kusuhara, Kazuhiro Kimura, Shunji Hasegawa, Yasuhiro Ikeda, Yuki Kodama, Hiroshi Moritake, Masayuki Ochiai, Shouichi Ohga, Junji Kishimoto, Koji Todaka, Ichiro Ieiri, Koh-Hei Sonoda

    Japanese journal of ophthalmology   68 ( 5 )   490 - 499   2024.9   ISSN:0021-5155 eISSN:1613-2246

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    PURPOSE: To assess the safety and efficacy of ripasudil for retinopathy of prematurity (ROP). STUDY DESIGN: Phase 1/2, multicenter, open-label, single-arm, 12-week clinical trial. METHODS: Infants born with gestational age (GA) of ≤ 32 weeks or weight of ≤ 1500 g with zone I or II, ≥ stage 1, ROP in both eyes were enrolled. Ripasudil eye drops were administered to patients in both eyes. Phase 1 was a dose-escalation study (once daily for 1 week, then twice daily for 2 weeks); an additional dosing up to 9 weeks was allowed if no safety issues occurred. In phase 2, ripasudil was administered twice daily for up to 12 weeks. Adverse events were assessed. The proportion of patients with type 1 ROP progression, number of days for type 1 ROP progression, and progression to the most advanced ROP stage were estimated. RESULTS: Twenty-four infants were enrolled (phase 1, n = 3; phase 2, n = 21). Nineteen and four patients experienced systemic and ocular adverse events, respectively. Efficacy endpoints were not different between the ripasudil and historical control groups. However, in the GA ≤ 27 weeks subgroup, fewer patients progressed to type 1 ROP in the ripasudil than in the historical control group (P = 0.09). In the GA ≤ 27 weeks subgroups, the 25th percentile for the number of days for type 1 ROP progression was 22 days in the historical control group and 44 days in the ripasudil group. CONCLUSION: Ripasudil was safe and inhibited/delayed type 1 ROP progression, especially in infants with short GA.

    DOI: 10.1007/s10384-024-01100-3

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  • Safety and efficacy of ripasudil eye drops in preterm infants with retinopathy of prematurity: phase 1/2, open label, single-arm trial(タイトル和訳中)

    Arima Mitsuru, Inoue Hirosuke, Misumi Akiko, Tsukamoto Shoko, Matsushita Itsuka, Araki Shunsuke, Ohta Manami, Takahashi Kazumasa, Imazato Miyuki, Goto Tomoko, Aoki Yoshinori, Tagawa Koshiro, Hirose Masayuki, Fujita Yuito, Yoshida Noriko, Nakao Shintaro, Kondo Hiroyuki, Kusuhara Koichi, Kimura Kazuhiro, Hasegawa Shunji, Ikeda Yasuhiro, Kodama Yuki, Moritake Hiroshi, Ochiai Masayuki, Ohga Shouichi, Kishimoto Junji, Todaka Koji, Ieiri Ichiro, Sonoda Koh-Hei

    Japanese Journal of Ophthalmology   68 ( 5 )   490 - 499   2024.9   ISSN:0021-5155

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  • Development of Deep-Learning Models for Real-Time Anaerobic Threshold and Peak VO2 Prediction during Cardiopulmonary Exercise Testing. Reviewed International journal

    Tatsuya Watanabe, Takeshi Tohyama, Masataka Ikeda, Takeo Fujino, Toru Hashimoto, Shouji Matsushima, Junji Kishimoto, Koji Todaka, Shintaro Kinugawa, Hiroyuki Tsutsui, Tomomi Ide

    Eur J Prev Cardiol.   31 ( 4 )   448 - 457   2024.3   ISSN:2047-4873 eISSN:2047-4881

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    Language:English   Publishing type:Research paper (scientific journal)   Publisher:European Journal of Preventive Cardiology  

    AIM: Exercise intolerance is a clinical feature of patients with heart failure (HF). Cardiopulmonary exercise testing (CPET) is the first-line examination for assessing exercise capacity in patients with HF. However, the need for extensive experience in assessing anaerobic threshold (AT) and the potential risk associated with the excessive exercise load when measuring peak oxygen uptake (peak VO2) limit the utility of CPET. This study aimed to use deep-learning approaches to identify AT in real-time during testing (defined as real-time AT) and to predict peak VO2 at real-time AT. METHODS: This study included the time-series data of CPET recorded at the Department of Cardiovascular Medicine, Kyushu University Hospital. Two deep neural network models were developed:1) to estimate the AT probability using breath-by-breath data, and 2) to predict peak VO2 using the data at the real-time AT. RESULTS: The eligible CPET were 1,472 records in 1,053 participants aged 18-90 years and 20% were used for model evaluation. The developed model identified real-time AT with 0.82 for correlation coefficient (Corr) and 1.20 mL/kg/min for mean absolute error (MAE), and the corresponding AT time with 0.86 for Corr and 0.66 min for MAE. The peak VO2 prediction model achieved 0.87 for Corr and 2.25 mL/kg/min for MAE. CONCLUSION: Deep-learning models for real-time CPET analysis can accurately identify AT and predict peak VO2. The developed models can be a competent assistant system to assess the patient's condition in real-time, expanding CPET utility.

    DOI: 10.1093/eurjpc/zwad375

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  • Fair Research Activities

    TODAKA Koji

    The Journal of The Japanese Society of Balneology, Climatology and Physical Medicine   87 ( 1 )   8 - 8   2024.2   ISSN:00290343 eISSN:18843697

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    Language:English   Publisher:The Japanese Society of Balneology, Climatology and Physical Medicine  

    DOI: 10.11390/onki.87_1.8

    CiNii Research

  • A Multicenter, Single-Blind, Randomized, Warfarin-Controlled Trial of Edoxaban in Patients With Chronic Thromboembolic Pulmonary Hypertension: KABUKI Trial

    Kazuya Hosokawa, Hiroko Watanabe, Yu Taniguchi, Nobutaka Ikeda, Takumi Inami, Satoshi Yasuda, Toyoaki Murohara, Masaru Hatano, Yuichi Tamura, Jun Yamashita, Koichiro Tatsumi, Ichizo Tsujino, Yuko Kobayakawa, Shiro Adachi, Nobuhiro Yaoita, Shun Minatsuki, Koji Todaka, Keiichi Fukuda, Hiroyuki Tsutsui, Kohtaro Abe

    Circulation   149 ( 5 )   406 - 409   2024.1   ISSN:0009-7322 eISSN:1524-4539

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    Language:English   Publishing type:Research paper (scientific journal)   Publisher:Ovid Technologies (Wolters Kluwer Health)  

    DOI: 10.1161/CIRCULATIONAHA.123.067528

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  • 治験におけるリモートSDVシステムの開発とその導入における取り組み

    田島 壮一郎, 中屋 純子, 坂梨 健二, 吉崎 真司, 高田 敦史, 武田 真樹, 船越 公太, 家入 一郎, 中島 直樹, 戸高 浩司

    日本臨床薬理学会学術総会抄録集   44回   2 - E5   2024.1   eISSN:2436-5580

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  • A Multicenter, Randomized, Warfarin-Controlled Trial of Edoxaban in Patients With Chronic Thromboembolic Pulmonary Hypertension: KABUKI Trial

    Hosokawa, K; Kishimoto, J; Taniguchi, Y; Ikeda, N; Inami, T; Yasuda, S; Murohara, T; Hatano, M; Tamura, Y; Yamashita, J; Tatsumi, K; Tsujino, I; Kobayakawa, Y; Adachi, S; Yaoita, N; Minatsuki, S; Todaka, K; Fukuda, K; Tsutsui, H; Abe, K

    CIRCULATION   148 ( 25 )   E309 - E309   2023.12   ISSN:0009-7322 eISSN:1524-4539

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  • 心房細動に対するアブレーション治療における3次元マップから心房細動の再発を予測するDeep learningモデルの開発

    遠山 岳詩, 坂本 和生, 戸高 浩司, 筒井 裕之

    福田記念医療技術振興財団情報   ( 36 )   205 - 212   2023.12

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    カテーテルアブレーションの施行中に記録される電位波高図の画像処理にDeep learningを活用することで再発リスクを予測するモデルを開発した。本モデルは、半年後および1年以内の早期再発に対して高い予測性能を示し、再発リスクに対する新たな層別化アプローチとしての有用性が示唆された。

  • ePathの概要とその活用、効果について

    中熊 英貴, 小妻 幸男, 山下 貴範, 若田 好史, 的場 哲哉, 松木 絵里, 船越 公太, 戸高 浩司, 中島 直樹, 岡田 美保子, 副島 秀久

    医療情報学連合大会論文集   43回   1101 - 1103   2023.11   ISSN:1347-8508 eISSN:2433-698X

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  • 疾患レジストリデータベースのコンピュータ化システムバリデーション対応

    宮原 冬佳, 川崎 史織, 山下 貴範, 平田 明恵, 池田 真一郎, 坂梨 健二, 船越 公太, 神田橋 忠, 戸高 浩司, 中島 直樹

    医療情報学連合大会論文集   43回   661 - 666   2023.11   ISSN:1347-8508 eISSN:2433-698X

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  • 上肢に運動機能障害を有する神経筋疾患患者における電子端末の利用状況調査 IT活用時の留意点を考える

    小早川 優子, 江 千里, 橋本 侑, 原田 幸子, 戸高 浩司, 山崎 亮, 磯部 紀子

    日本難病医療ネットワーク学会機関誌   11 ( 1 )   133 - 133   2023.11   ISSN:2188-1006

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  • スタチンおよびエゼチミブによる脂質低下療法中の血清オキシステロールと冠動脈プラーク退縮との関連性 CuVIC試験からの知見(Association between Serum Oxysterols and Coronary Plaque Regression during Lipid-Lowering Therapy with Statin and Ezetimibe: Insights from the CuVIC Trial)

    Nakano Yasuhiro, Yamamoto Mitsutaka, Matoba Tetsuya, Katsuki Shunsuke, Nakashiro Soichi, Takase Susumu, Akiyama Yusuke, Nagata Takuya, Mukai Yasushi, Inoue Shujiro, Oi Keiji, Higo Taiki, Takemoto Masao, Suematsu Nobuhiro, Eshima Kenichi, Miyata Kenji, Usui Makoto, Sadamatsu Kenji, Kadokami Toshiaki, Hironaga Kiyoshi, Ichi Ikuyo, Todaka Koji, Kishimoto Junji, Tsutsui Hiroyuki

    Journal of Atherosclerosis and Thrombosis   30 ( 8 )   907 - 918   2023.8   ISSN:1340-3478

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    冠動脈ステント留置術を受けた冠動脈疾患の患者をスタチン(S)またはSとエゼチミブの併用(S+E)で治療するCuVIC試験から、治療前と6~8ヵ月追跡調査後の非責任病変の血管内超音波(IVUS)画像が得られた79症例(S群39名、S+E群40名)を抽出し解析した。治療期間後のS+E群のLDL-コレステロール(LDL-C)値はS群と比べて有意に低かった。S+E群ではコレステロール吸収のマーカーであるcampesterol、オキシステロール(β-epoxycholesterol、4β-hydroxycholesterol、27-hydroxycholesterol)も低かった。IVUS解析でS+E群のプラーク退縮率はS群と比べて大きかった。campesterolおよび27-hydroxycholesterolの低下はプラーク退縮と正相関し、LDL-Cの低下は相関しなかった。

  • Long-term outcome of chronic thromboembolic pulmonary hypertension using direct oral anticoagulants and warfarin: a Japanese prospective cohort study. International journal

    Kazuya Hosokawa, Kohtaro Abe, Kouta Funakoshi, Yuichi Tamura, Naoki Nakashima, Koji Todaka, Yu Taniguchi, Takumi Inami, Shiro Adachi, Ichizo Tsujino, Jun Yamashita, Shun Minatsuki, Nobutaka Ikeda, Hiroto Shimokawahara, Takashi Kawakami, Takeshi Ogo, Masaru Hatano, Hitoshi Ogino, Yoshihiro Fukumoto, Nobuhiro Tanabe, Hiromi Matsubara, Keiichi Fukuda, Koichiro Tatsumi, Hiroyuki Tsutsui

    Journal of thrombosis and haemostasis : JTH   21 ( 8 )   2151 - 2162   2023.8   ISSN:1538-7933 eISSN:1538-7836

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    BACKGROUND: Chronic thromboembolic pulmonary hypertension (CTEPH) requires lifelong anticoagulation. Long-term outcomes of CTEPH under current anticoagulants are unclear. OBJECTIVES: The CTEPH AC registry is a prospective, nationwide cohort study comparing the safety and effectiveness of direct oral anticoagulants (DOACs) and warfarin for CTEPH. PATIENTS/METHODS: Patients with CTEPH, both tre atment-naïve and on treatment, were eligible for the registry. Inclusion criteria were patients aged ≥20 years and those who were diagnosed with CTEPH according to standard guidelines. Exclusion criteria were not specified. The primary efficacy outcome was a composite morbidity, and mortality outcome comprised all-cause death, rescue reperfusion therapy, initiation of parenteral pulmonary vasodilators, and worsened 6-minute walk distance and WHO functional class. The safety outcome was clinically relevant bleeding, including major bleeding. RESULTS: Nine hundred twenty-seven patients on oral anticoagulants at baseline were analyzed: 481 (52%) used DOACs and 446 (48%) used warfarin. The 1-, 2-, and 3-year rates of composite morbidity and mortality outcome were comparable between the DOAC and warfarin groups (2.6%, 3.1%, and 4.2% vs 3.0%, 4.8%, and 5.9%, respectively; P = .52). The 1-, 2-, and 3-year rates of clinically relevant bleeding were significantly lower in DOACs than in the warfarin group (0.8%, 2.4%, and 2.4% vs 2.5%, 4.8%, and 6.4%, respectively; P = 0.036). Multivariable Cox proportional-hazards regression models revealed lower risk of clinically relevant bleeding in the DOAC group than the warfarin group (hazard ratio: 0.35; 95% CI: 0.13-0.91; P = .032). CONCLUSION: This registry demonstrated that under current standard of care, morbidity and mortality events were effectively prevented regardless of anticoagulants, while the clinically relevant bleeding rate was lower when using DOACs compared with warfarin.

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  • Association of Serum Oxysterols with Cholesterol Metabolism Markers and Clinical Factors in Patients with Coronary Artery Disease: A Covariance Structure Analysis

    Akiyama, Y; Katsuki, S; Matoba, T; Nakano, Y; Takase, S; Nakashiro, S; Yamamoto, M; Mukai, Y; Inoue, S; Oi, K; Higo, T; Takemoto, M; Suematsu, N; Eshima, K; Miyata, K; Usui, M; Sadamatsu, K; Kadokami, T; Hironaga, K; Ichi, I; Todaka, K; Kishimoto, J; Tsutsui, H

    NUTRIENTS   15 ( 13 )   2023.7   eISSN:2072-6643

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    Oxysterols have been implicated in the pathogenesis of cardiovascular diseases. Serum levels of oxysterols could be positively correlated with cholesterol absorption and synthesis. However, physiological regulation of various serum oxysterols is largely unknown. The aim of this study was to investigate the relationship between clinical factors and cholesterol metabolism markers, and identify oxysterols associated with cholesterol absorption and synthesis in patients with coronary artery disease. Subjects (n = 207) who underwent coronary stenting between 2011 and 2013 were studied cross-sectionally. We measured lipid profiles including serum oxysterols. As for the serum biomarkers of cholesterol synthesis and absorption, oxysterol levels were positively correlated with campesterol and lathosterol. Covariance structure analysis revealed that dyslipidemia and statin usage had a positive correlation with “cholesterol absorption”. Statin usage also had a positive correlation with “cholesterol synthesis”. Several oxysterols associated with cholesterol absorption and/or synthesis. In conclusion, we elucidated the potential clinical factors that may affect cholesterol metabolism, and the associations between various oxysterols with cholesterol absorption and/or synthesis in patients with coronary artery disease.

    DOI: 10.3390/nu15132997

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  • Association of Serum Oxysterols with Cholesterol Metabolism Markers and Clinical Factors in Patients with Coronary Artery Disease: A Covariance Structure Analysis. Reviewed International journal

    Akiyama Y, Katsuki S, Matoba T, Nakano Y, Takase S, Nakashiro S, Yamamoto M, Mukai Y, Inoue S, Oi K, Higo T, Takemoto M, Suematsu N, Eshima K, Miyata K, Usui M, Sadamatsu K, Kadokami T, Hironaga K, Ichi I, Todaka K, Kishimoto J, Tsutsui H.

    Nutrients.   2023.6

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    DOI: 10.3390/nu15132997.

  • クリニカルパスの標準化とその効果

    若田 好史, 山下 貴範, 中熊 英貴, 的場 哲哉, 船越 公太, 戸高 浩司, 岡田 美保子, 中島 直樹, 副島 秀久

    日本医療情報学会春季学術大会プログラム・抄録集   27回   106 - 107   2023.6

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  • Long-term outcome of chronic thromboembolic pulmonary hypertension using direct oral anticoagulants and warfarin: a Japanese prospective cohort study. Reviewed International journal

    Hosokawa K, Abe K, Funakoshi K, Tamura Y, Nakashima N, Todaka K, Taniguchi Y, Inami T, Adachi S, Tsujino I, Yamashita J, Minatsuki S, Ikeda N, Shimokawahara H, Kawakami T, Ogo T, Hatano M, Ogino H, Fukumoto Y, Tanabe N, Matsubara H, Fukuda K, Tatsumi K, Tsutsui H.

    J Thromb Haemost.   2023.4

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    DOI: 10.1016/j.jtha.2023.03.036.

  • 糖尿病診療のデジタルヘルスの展開 分散型臨床試験DCTとデジタルヘルス

    戸高 浩司, 船越 公太, 中島 直樹, 山下 貴範

    糖尿病   66 ( Suppl.1 )   S - 60   2023.4   ISSN:0021-437X eISSN:1881-588X

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  • Long-Term Outcomes of Heart Failure Patients With Preserved, Mildly Reduced, and Reduced Ejection Fraction

    Takuya Nagata, Tomomi Ide, Takeshi Tohyama, Hidetaka Kaku, Nobuyuki Enzan, Shouji Matsushima, Masataka Ikeda, Koji Todaka, Hiroyuki Tsutsui

    JACC: Asia   3 ( 2 )   315 - 316   2023.3   eISSN:2772-3747

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    DOI: 10.1016/j.jacasi.2022.11.013

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  • Deep Learning of ECG for the Prediction of Postoperative Atrial Fibrillation.ial. Reviewed International journal

    Tohyama T, Ide T, Ikeda M, Nagata T, Tagawa K, Hirose M, Funakoshi K, Sakamoto K, Kishimoto J, Todaka K, Nakashima N, Tsutsui H.

    Circ Arrhythm Electrophysiol.   16 ( 2 )   110 - 112   2023.2   ISSN:1941-3149 eISSN:1941-3084

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    Language:English   Publishing type:Research paper (scientific journal)   Publisher:Circulation: Arrhythmia and Electrophysiology  

    DOI: 10.1161/CIRCEP.122.011579

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  • 治験におけるリモートSDVシステムの開発とその導入における取り組み

    田島 壮一郎, 中屋 純子, 坂梨 健二, 吉崎 真司, 高田 敦史, 武田 真樹, 船越 公太, 家入 一郎, 中島 直樹, 戸高 浩司

    Annual Scientific Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics   44 ( 0 )   2-C-P-E5   2023   eISSN:24365580

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    <p>【目的】原資料の直接閲覧(SDV:Source Data Verification)は、治験データの信頼性確保のためにGCP上定められている。近年、多施設共同試験の増加や実施医療機関ごとの被験者数減少により、SDVに多大な労力やコストを費やしていることが問題となっている。効率化のために「臨床研究・治験活性化5か年計画2012」でリモートSDVの推進が提言され、医療機関側で様々な取り組みが行われている。今回、九州大学病院においてセキュアな環境を用いた新たなリモートSDVシステムを開発し、導入したので紹介する。【方法】医師向けの病院敷地外からも電子カルテの画面を操作・閲覧することを可能とするシステムが別目的で存在していた。厚生労働省の「医療情報システムの安全管理に関するガイドライン」に準拠し、VPN(Virtual Private Network)の暗号化通信回線を用いて仮想デスクトップ(VDI:Virtual Desktop Infrastructure)上で電子カルテを閲覧することとした。閲覧者の本人確認は通常の電子カルテと同じで生体認証(手のひら静脈認証)とした。また、運用開始前に協力の得られた3試験において、リモートSDVを試行し、問題点の抽出と対応について検討した。【結果・考察】専用モバイルPCをSDV用に権限、周辺システムなどの閲覧可能な範囲をカスタマイズしたリモートSDV用端末として、治験依頼者に貸し出し、リモートSDV用端末~VDI端末にVPNを構築し、通信内容を秘匿した状態でセキュアに電子カルテを閲覧できるようにした。リモートSDV用端末にはCLOMOの位置情報監視機能を利用し、SDV用の隔離した個室等、事前に登録した場所以外では閲覧できない設定とした。また、リモートSDV用端末の貸与は治験依頼者と契約を締結し、閲覧できる患者は該当する試験の被験者のみとした。試行の結果、遠隔地からVPN機能を用いて安全にリモートSDVの実施が可能であることを確認したため、2023年4月より本格運用を開始している。【結論】VDI機能とVPN技術を組み合わせたセキュアな環境により、安全なリモートSDVの実施が可能となった。リモートSDVの導入により、モニタリングの効率化による品質向上やコスト削減等のメリットが見込まれる。</p>

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  • 医師主導治験の具体的事例から見るAROの役割

    戸高 浩司

    Annual Scientific Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics   44 ( 0 )   3-C-S42-2   2023   eISSN:24365580

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    <p>当AROでは臨床現場に新薬等を届けることを使命とし、薬事承認の出口として医師主導治験に注力している。「ハイリスク症候性人工弁周囲逆流に対する経カテーテル逆流閉鎖術の安全性及び有効性を検討する医師主導治験」及び「レジストリを活用した慢性血栓塞栓性肺高血圧症に対するエドキサバンの適応拡大のための第III相医師主導治験」等、成果の出た・出つつあるシーズ支援を通して、AROの役割について論じる。</p>

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  • 九州大学病院における治験関連文書の電磁的管理システムに対するモニタリング担当者の評価

    三木 翔伍, 田島 壮一郎, 田中 瑠美, 高平 育子, 下條 晃, 武田 真樹, 家入 一郎, 戸高 浩司

    Annual Scientific Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics   44 ( 0 )   2-C-P-E4   2023   eISSN:24365580

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    <p>【目的】九州大学病院では、2022年12月よりクラウドシステム(Agatha)を用いて治験関連文書の電磁的管理を開始している。モニタリング業務や申請資料の作成、提出を担っているCRAを対象にアンケート調査を行い、当院での電磁化システムの環境をどのように評価しているかを検討した。【方法】2023年5月時点で実施中の企業治験(196試験)において、Agathaを利用している当院担当のCRA 166人を対象にwebアンケート調査を行った。アンケートはREDCapを用いて作成し、各個人の自主的なweb入力により回答を得た。主な調査項目は、「IRB審議資料の提出のしやすさ」や「電磁化導入前と比較した業務量の変化」といった内容とした。【結果・考察】対象者166人のうち114人(68.6%)から回答が得られた。回答者の所属機関はCROが92人(80.7%)、製薬企業が22人であった。「IRB審議資料の提出のしやすさ」の質問に「とても提出しやすい」「提出しやすい」と112人が回答し、2人は「提出したことがない」と回答した。「業務量の変化」については、「かなり減った」「減った」と94人が回答し、「変わらない」7人、「導入前を知らない」13人であった。軽減した業務は、「IRB審議資料の提出」が最も多く91人、次いで「文書の授受」57人、「責任医師保管文書の提出」38人であった。また電磁化システムの環境については「アップロード時の作業工程が少ない」、「システム内での書式作成がないため使い易い」との好意的な意見が多かった。一方、「保管文書一覧の抽出機能がない」、「システム上で責任医師による確認ができない」といった追加機能に関する要望もあった。本アンケート調査の結果より、治験関連文書の電磁的保管によって資料の授受についてはモニタリング業務の効率化に寄与していると考えられたが、一方、保管文書一覧の抽出や責任医師の確認方法に関しては、治験業務の効率的な運用を目指す上で今後の課題と考える。</p>

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  • DCTと臨床研究中核病院、eWorksheet

    戸高 浩司

    Annual Scientific Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics   44 ( 0 )   2-C-S30-3   2023   eISSN:24365580

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    <p>臨床研究中核病院ではReal World Evidence創出基盤の構築に2018年度より取り組み、電子カルテから品質の高いデータ抽出が実施されている。しかしながら観察研究であるため、通常診療に用いない有効性指標を収集したり、定期的な評価スケジュール(ビジット)を設定するなど、介入試験に特有なものには対応が難しい。 これらの課題に対応すべく標準化電子ワークシートを開発した。2018~20年度、標準クリニカルパス(ePath日本医療情報学会標準)を開発、電子カルテに実装しており、ベンダー横断的に標準業務実施、標準化データ収集が可能である。 このePathを下敷にした標準化電子ワークシートを実装し、治験実施の上、電子カルテ/ワークシートとEDCの連結を可能とする。 </p><p>同時に、治験実施を促進する分散型臨床試験(DCT)の枠組みを臨床研究中核病院中心に整備している。DCTには大きく分けて、規制面、技術面、運用面の課題がある。規制面の課題は主に厚労省マターであり2022年度以降に発出されるガイダ ンス群を待たねばならないが、AMED先進的臨床研究環境基盤整備プログラムでは、技術面、運用面での整備を行った。 技術面に関しては、DCTを構成する複数の要素(eConsent、eCOA、遠隔診療等)を包括的に運用し記録を効率化するため に標準化電子ワークシートを用いる。 一方、運用面の整備としてDCTを実施するための要素群を統合して運用するために必要なSOP等の作成支援とトレーニングを行った。軽症COVID-19を対象とする経口治療薬を想定した模擬プロトコルを用いて全臨床研究中核病院で模擬治験を実施し、各施設での運用の課題を抽出し対応を行った。</p>

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  • Association between Serum Oxysterols and Coronary Plaque Regression during Lipid-Lowering Therapy with Statin and Ezetimibe: Insights from the CuVIC Trial.

    Yasuhiro Nakano, Mitsutaka Yamamoto, Tetsuya Matoba, Shunsuke Katsuki, Soichi Nakashiro, Susumu Takase, Yusuke Akiyama, Takuya Nagata, Yasushi Mukai, Shujiro Inoue, Keiji Oi, Taiki Higo, Masao Takemoto, Nobuhiro Suematsu, Kenichi Eshima, Kenji Miyata, Makoto Usui, Kenji Sadamatsu, Toshiaki Kadokami, Kiyoshi Hironaga, Ikuyo Ichi, Koji Todaka, Junji Kishimoto, Hiroyuki Tsutsui

    Journal of atherosclerosis and thrombosis   30 ( 8 )   907 - 918   2022.12   ISSN:13403478 eISSN:18803873

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    <p> <b>Aim:</b> Several clinical trials using intravascular ultrasound (IVUS) evaluation have demonstrated that intensive lipid-lowering therapy by statin or a combination therapy with statin and ezetimibe results in significant regression of coronary plaque volume. However, it remains unclear whether adding ezetimibe to statin therapy affects coronary plaque composition and the molecular mechanisms of plaque regression. We conducted this prospective IVUS analysis in a subgroup from the CuVIC trial.</p><p><b>Methods:</b> The CuVIC trial was a prospective randomized, open, blinded-endpoint trial conducted among 11 cardiovascular centers, where 260 patients with coronary artery disease who received coronary stenting were randomly allocated into either the statin group (S) or the combined statin and ezetimibe group (S+E). We enrolled 79 patients (S group, 39 patients; S+E group, 40 patients) in this substudy, for whom serial IVUS images of nonculprit lesion were available at both baseline and after 6–8 months of follow-up.</p><p><b>Results:</b> After the treatment period, the S+E group had significantly lower level of low-density lipoprotein cholesterol (LDL-C; 80.9±3.7 vs. 67.7±3.8 mg/dL, <i>p</i>=0.0143). Campesterol, a marker of cholesterol absorption, and oxysterols (β-epoxycholesterol, 4β-hydroxycholesterol, and 27-hydroxycholesterol) were also lower in the S+E group. IVUS analyses revealed greater plaque regression in the S+E group than in the S group (−6.14% vs. −1.18% for each group, <i>p</i>=0.042). It was noteworthy that the lowering of campesterol and 27-hydroxycholesterol, but not LDL-C, had a significant positive correlation with plaque regression.</p><p><b>Conclusions:</b> Compared with statin monotherapy, ezetimibe in combination with statin achieved significantly lower LDL-C, campesterol, and 27-hydroxycholesterol, which resulted in greater coronary plaque regression.</p>

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  • Intravenous vagal stimulation catheter, JOHAKU, rapidly decreases heart rate and myocardial oxygen consumption without worsening hemodynamics

    Yokota, S; Kakuuchi, M; Yokoi, A; Kawada, T; Uemura, K; Ishida, E; Sakamoto, K; Todaka, K; Saku, K

    EUROPEAN HEART JOURNAL   43   566 - 566   2022.10   ISSN:0195-668X eISSN:1522-9645

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  • Efficacy and safety of edoxaban in patients with chronic thromboembolic pulmonary hypertension: protocol for a multicentre, randomised, warfarin-controlled, parallel group trial-KABUKI trial

    Kazuya Hosokawa, Kohtaro Abe, Junji Kishimoto, Yuko Kobayakawa, Koji Todaka, Yuichi Tamura, Koichiro Tatsumi, Takumi Inami, Nobutaka Ikeda, Yu Taniguchi, Shun Minatsuki, Toyoaki Murohara, Satoshi Yasuda, Keiichi Fukuda, Hiroyuki Tsutsui

    BMJ Open   12 ( 7 )   e061225   2022.7   ISSN:2044-6055 eISSN:2044-6055

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    Introduction Chronic thromboembolic pulmonary hypertension (CTEPH) is a complication of prior pulmonary thromboembolism (PE), caused by incomplete clot dissolution after PE. In patients with CTEPH, lifelong anticoagulation is mandatory to prevent recurrence of PE and secondary in situ thrombus formation. Warfarin, a vitamin K antagonist, is commonly used for anticoagulation in CTEPH based on historical experience and evidence. The anticoagulant activity of warfarin is affected by food and drug interactions, requiring regular monitoring of prothrombin time. The lability of anticoagulant effect often results in haemorrhagic and thromboembolic complications. Thus, lifelong warfarin is a handicap in terms of safety and convenience. Currently, the use of direct oral anticoagulants (DOACs) in CTEPH has increased with the advent of four DOACs. The safety of DOACs is superior to warfarin, with less intracranial bleeding in patients with non-valvular atrial fibrillation and venous thromboembolism. Edoxaban, the latest DOAC, also has proven efficacy and safety for those diseases in two large clinical trials; the ENGAGE-AF trial and HOKUSAI-VTE trial. The present trial seeks to evaluate whether edoxaban is non-inferior to warfarin in preventing worsening of CTEPH. Methods and analysis The KABUKI trial (is an investigator-initiated, multicentre, phase 3, randomised, single-blind, parallel-group, warfarin-controlled, non-inferiority trial to evaluate the efficacy and safety of edoxaban versus warfarin (vitamin K Antagonist) in subjects with chronic thromBoembolic pUlmonary hypertension taking warfarin (vitamin K antagonIst) at baseline) is designed to prove the non-inferiority of edoxaban to warfarin in terms of efficacy and safety in patients with CTEPH. Ethics and dissemination This study is approved by the Institutional Review Board of each participating institution. The findings will be published in a peer-reviewed journal, including positive, negative and inconclusive results. Trial registration number NCT04730037. Protocol version This paper was written per the study protocol V.4.0, dated 29 January 2021.

    DOI: 10.1136/bmjopen-2022-061225

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  • Safety, tolerability, and anti-fibrotic efficacy of the CBP/β-catenin inhibitor PRI-724 in patients with hepatitis C and B virus-induced liver cirrhosis: An investigator-initiated, open-label, non-randomised, multicentre, phase 1/2a study

    Kiminori Kimura, Tatsuya Kanto, Shinji Shimoda, Kenichi Harada, Masamichi Kimura, Koji Nishikawa, Jun Imamura, Eiichi Ogawa, Masanao Saio, Yoshihiro Ikura, Takuji Okusaka, Kazuaki Inoue, Tetsuya Ishikawa, Ichiro Ieiri, Junji Kishimoto, Koji Todaka, Terumi Kamisawa

    eBioMedicine   80   104069   2022.6   ISSN:2352-3964 eISSN:2352-3964

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    Background: We conducted an exploratory study to assess the safety tolerability, and anti-fibrotic effects of PRI-724, a CBP/β-catenin inhibitor, in patients with hepatitis C virus (HCV)- and hepatitis B virus (HBV)-induced cirrhosis. Methods: This multicentre, open-label, non-randomised, non-placebo-controlled phase 1/2a trial was conducted at three hospitals in Japan. Between July 27, 2018, and July 13, 2021, we enrolled patients with HCV- and HBV-induced cirrhosis classified as Child–Pugh (CP) class A or B. In phase 1, 15 patients received intravenous infusions of PRI-724 at escalating doses of 140, 280, and 380 mg/m2/4 h twice weekly for 12 weeks. In phase 2a, 12 patients received the recommended PRI-724 dose. The primary endpoints of phases 1 and 2a were the frequency and severity of adverse events and efficacy in treating cirrhosis based on liver biopsy. This study was registered at ClinicalTrials.gov (no. NCT 03620474). Findings: Three patients from phase 1 who received the recommended PRI-724 dose were evaluated to obtain efficacy and safety data in phase 2a. Serious adverse events occurred in three patients, one of which was possibly related to PRI-724. The most common adverse events were diarrhoea and nausea. PRI-724 did not decrease hepatic fibrosis with any statistical significance, either by ordinal scoring or measurement of collagen proportionate area at 12 weeks; however, we observed statistically significant improvements in liver stiffness, Model for End-stage Liver Disease score, and serum albumin level. Interpretation: Intravenous administration of 280 mg/m2/4 h PRI-724 over 12 weeks was preliminarily assessed to be well tolerated; however, further evaluation of anti-fibrotic effects in patients with cirrhosis is warranted. Funding: AMED, Ohara Pharmaceutical

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  • 治験に関わる薬剤師のトレーニングの現状とその評価

    Hasebe Yui, Nishida Tomoko, Takagi Masae, Tanaka Chika, Tanaka Sarine, Miki Shogo, Ryokai Yuriko, Tanaka Rumi, Tajima Soichiro, Sakaguchi Hiromi, Todaka Koji, Ieiri Ichiro

    Annual Scientific Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics   43 ( 0 )   2-C-P-047   2022   eISSN:24365580

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    <p>【目的】治験薬の作用機序や製剤特性の多様化・複雑化に伴い、非盲検薬剤師が必要となる場合や、製剤的な側面から調剤・調製方法が煩雑になる場合も多く、治験における薬剤師の重要性が高まっている。こうした複雑な治験に関与する薬剤師に対し、Risk based Approachに基づく適切なトレーニングを行うことは、治験の質向上という観点からも重要である。しかしながら、求められるトレーニング内容や形式は試験ごとに異なるため、Quality Management System(QMS)の観点からトレーニングの現状について調査を行った。【方法】2018~2021年度に九州大学病院が契約を行った企業治験のうち、当院で治験開始前に中止となった試験を除く174試験を対象に調査を実施した。その中で、2022年6月までに治験依頼者が提示を求めたトレーニングについて、トレーニング内容及び件数、対象者、契約年度、治験デザイン、非盲検薬剤師の有無に関する評価を行った。【結果・考察】薬剤師に対して治験開始時の初回トレーニングを求めた治験は127試験であり、そのうちの74.0%(94試験)が国際共同試験であった。また、契約年度毎にみると初回トレーニングを求めたものは、2018年度の60.9%から2021年度の77.8%へと経年的に増加した。一方、治験情報の改訂に伴うトレーニングを求めた試験は75試験(336件)であり、その内訳は、治験薬管理手順書関連が31.3%(105件)、プロトコール関連が28.6%(96件)、治験薬概要書関連が26.5%(89件)、IRT関連5.4%(18件)、盲検化手順関連が2.4%(8件)などであった。なお、このうち3割の試験において、軽微な変更のトレーニングを求めた事例や、試験途中でトレーニング対象者や内容を変更した事例、事実と異なる記録の作成や詳細に記載方法を指定した記録を求めた事例が見られた。また、非盲検薬剤師が必要な試験(23試験)のうち65.2%(15試験)が治験情報の改訂に伴うトレーニングを求めたが、非盲検薬剤師が不要な試験(151試験)では39.7%(60試験)と、リスクに応じた対策に違いが見られた。【結論】ICH-E6(R2)の改訂に伴い治験の品質管理にQMSの必要性が明記され、Risk based Approachに基づいたトレーニングが求められている。しかし、トレーニングの記録作成を重視するあまり、治験の質向上という本質が欠如した内容も散見された。QMSの概念に基づくトレーニングのあり方を規制当局、依頼者、実施施設が共に検討していく必要があると考える。</p>

    DOI: 10.50993/jsptsuppl.43.0_2-c-p-047

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  • 本邦における医師主導治験の役割について

    Todaka Koji

    Annual Scientific Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics   43 ( 0 )   4-C-S44-2   2022   eISSN:24365580

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    <p>2003年に薬事法が改正され「医師主導治験」という世界的に見ても特異な制度が始まった。製薬会社等が開発・治験を実施してくれない採算性の低い製品・適応に対して、医師が自ら薬事承認のための臨床試験を計画・設計・実施する。最終的にそのデータを製薬会社等が承認申請に用いるという本質的に捻れた仕組みを持ち、元々はドラッグラグ、デバイスラグ等を解消する手段の一つとして始められた。昨今は企業開発品の初期治験でさえアカデミアに任せ、ある程度医師主導治験で成績が出るまで様子見をするという企業が出て来ているのも事実である。7月時点のjRCTで実施中の未承認薬医師主導治験が43試験ある。うち15件(35%)は研究資金等の提供組織として製薬企業も記載されている。適応外薬も同じく43試験あり、21件(49%)は製薬企業も記載されている。AMED公募において「なぜ企業治験ではないのか?」としばしば問題となるが、市場性が低い製品の臨床開発をどこが負担して実施すべきかについて明確な基準が無く、未だコンセンサスは得られていない。 </p><p>リポジショニングでよく見受ける特許切れ成分の新作用機序が臨床ニーズを満たす場合、臨床現場で発したneeds pull開発として医療従事者の熱意で推進するものの、必ずしも市場が要求したmarket pullではないことから来る弊害もある。研究費を獲得して医師主導治験を実施し有効性を証明して、先発薬を適応拡大できたとしても、沢山ある後発薬と差別化が難しい。用途特許等で法的に保護する事は可能であるが、後発薬の適応外使用を止める実効性には乏しい。従って採算が取れる目処が無いなどの理由により企業が承認申請を請け負わない場合がある。国内であまねく使用できるようにするという医師主導治験の本来目的は出口で頓挫してしまう。米国では保険適用を伴った臨床使用が薬事承認範囲を超えてcompendiaという形で広く認められているため、適応拡大に限れば我が国の保険行政特有の問題と言える。 </p><p>制度開始から20年近くたち、ARO初めとして現場は医師主導治験に慣れてきたが上記のような弊害も目立つ。アカデミアも企業もこの特有な制度を今後どのように活用して行くのか、規制当局とともに再考する時期に来ている。</p>

    DOI: 10.50993/jsptsuppl.43.0_4-c-s44-2

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  • Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation Reviewed International journal

    Nakamura K, Ozawa H, Shibata T, Ushirozawa N, Hata T, Okita N, Fuse N, Sato N, Ikeda K, Hanaoka H, Maruyama T, Wada M, Shimizu S, Kasai H, Yamamoto Y, Sakurai J, Todaka K, Tashiro S, Yamamoto H.

    Ther Innov Regul Sci.   17   1 - 10   2021.11

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    DOI: 10.1007/s43441-021-00350-4.

  • Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation

    Kenichi Nakamura, Hitoshi Ozawa, Taro Shibata, Nobuko Ushirozawa, Tomomi Hata, Natsuko Okita, Nozomu Fuse, Norihiro Sato, Koji Ikeda, Hideki Hanaoka, Tatsuya Maruyama, Michihiko Wada, Shinobu Shimizu, Hiroi Kasai, Yoichi Yamamoto, Jun Sakurai, Koji Todaka, Shimon Tashiro, Haruko Yamamoto

    Therapeutic Innovation & Regulatory Science   56 ( 2 )   220 - 229   2021.11   ISSN:2168-4790 eISSN:2168-4804

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    <jats:title>Abstract</jats:title><jats:sec>
    <jats:title>Background</jats:title>
    <jats:p>The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is undertaking a major revision of ICH E6 Good Clinical Practice (GCP) decided to involve external stakeholders in ICH-GCP renovation. Activities such as surveys and public conferences have taken place in the United States, European Union, and Japan. For stakeholder engagement in Japan, a designated research group conducted a survey of academic stakeholders.</jats:p>
    </jats:sec><jats:sec>
    <jats:title>Methods</jats:title>
    <jats:p>A total of 105 academic stakeholders from 18 institutions responded to the survey. The research group developed recommendations reflecting the survey results and the opinions from patients and the public.</jats:p>
    </jats:sec><jats:sec>
    <jats:title>Results</jats:title>
    <jats:p>The survey showed the top four principles needing renovation were (i) informed consent (Chapter 2.9, 12.4% of respondents believed it needed renovation), (ii) systems for quality assurance (Chapter 2.13, 9.5%), (iii) information on an investigational product (Chapter 2.4, 5.7%), and (iv) procedures on clinical trial information (Chapter 2.10, 5.7%). The top three sections identified as needing renovation were: (i) informed consent (Chapter 4.8, 27.6%), (ii) monitoring (Chapter 5.18, 22.9%), and (iii) composition, functions, and operations of the ethics committee (Chapter 3.2, 14.3%). Recommendations included clarification of ICH-GCP’s scope, proportionality in various aspects of clinical trials, diversity and liquidity of ethics committee members, modernization of informed consent procedures, variations in monitoring, and regulatory grade when using real-world data.</jats:p>
    </jats:sec><jats:sec>
    <jats:title>Conclusion</jats:title>
    <jats:p>The recommendations from Japanese investigators and patients have been submitted to the ICH E6 Expert Working Group, which will strengthen the robustness of the GCP renovation. </jats:p>
    </jats:sec>

    DOI: 10.1007/s43441-021-00350-4

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  • Machine learning-based model for predicting 1 year mortality of hospitalized patients with heart failure

    Takeshi Tohyama, Tomomi Ide, Masataka Ikeda, Hidetaka Kaku, Nobuyuki Enzan, Shouji Matsushima, Kouta Funakoshi, Junji Kishimoto, Koji Todaka, Hiroyuki Tsutsui

    ESC Heart Failure   8 ( 5 )   4077 - 4085   2021.10

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    Aims: Individual risk stratification is a fundamental strategy in managing patients with heart failure (HF). Artificial intelligence, particularly machine learning (ML), can develop superior models for predicting the prognosis of HF patients, and administrative claim data (ACD) are suitable for ML analysis because ACD is a structured database. The objective of this study was to analyse ACD using an ML algorithm, predict the 1 year mortality of patients with HF, and finally develop an easy-to-use prediction model with high accuracy using the top predictors identified by the ML algorithm. Methods and results: Machine learning-based prognostic prediction models were developed from the ACD on 10 175 HF patients from the Japanese Registry of Acute Decompensated Heart Failure with 17% mortality during 1 year follow-up. The top predictors for prognosis in HF were identified by the permutation feature importance technique, and an easy-to-use prediction model was developed based on these predictors. The c-statistics and Brier scores of the developed ML-based models were compared with those of conventional risk models: Seattle Heart Failure Model (SHFM) and Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC). A voting classifier algorithm (ACD-VC) achieved the highest c-statistics among the six ML algorithms. The permutation feature importance technique enabled identification of the top predictors such as Barthel index, age, body mass index, duration of hospitalization, last hospitalization, renal disease, and non-loop diuretics use (feature importance values were 0.054, 0.025, 0.010, 0.005, 0.005, 0.004, and 0.004, respectively). Upon combination of some of the predictors that can be assessed from a brief interview, the Simple Model by ARTificial intelligence for HF risk stratification (SMART-HF) was established as an easy-to-use prediction model. Compared with the conventional models, SMART-HF achieved a higher c-statistic {ACD-VC: 0.777 [95% confidence interval (CI) 0.751–0.803], SMART-HF: 0.765 [95% CI 0.739–0.791], SHFM: 0.713 [95% CI 0.684–0.742], MAGGIC: 0.726 [95% CI 0.698–0.753]} and better Brier scores (ACD-VC: 0.121, SMART-HF: 0.124, SHFM: 0.139, MAGGIC: 0.130). Conclusions: The ML model based on ACD predicted the 1 year mortality of HF patients with high accuracy, and SMART-HF along with the ML model achieved superior performance to that of the conventional risk models. The SMART-HF model has the clear merit of easy operability even by non-healthcare providers with a user-friendly online interface (https://hfriskcalculator.herokuapp.com/). Risk models developed using SMART-HF may provide a novel modality for risk stratification of patients with HF.

    DOI: 10.1002/ehf2.13556

  • An Open-label Phase I/IIa Clinical Trial of 11β-HSD1 Inhibitor for Cushing’s Syndrome and Autonomous Cortisol Secretion

    Satoko Oda, Kenji Ashida, Makiko Uchiyama, Shohei Sakamoto, Nao Hasuzawa, Ayako Nagayama, Lixiang Wang, Hiromi Nagata, Ryuichi Sakamoto, Junji Kishimoto, Koji Todaka, Yoshihiro Ogawa, Yoichi Nakanishi, Masatoshi Nomura

    The Journal of Clinical Endocrinology & Metabolism   106 ( 10 )   e3865 - e3880   2021.9

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    <jats:title>Abstract</jats:title>
    <jats:sec>
    <jats:title>Context</jats:title>
    <jats:p>11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) inhibitors demonstrate antimetabolic and antisarcopenic effects in Cushing’s syndrome (CS) and autonomous cortisol secretion (ACS) patients.</jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>Objective</jats:title>
    <jats:p>To confirm the efficacy and safety of S-707106 (11β-HSD1 inhibitor) administered to CS and ACS patients.</jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>Design</jats:title>
    <jats:p>A 24-week single-center, open-label, single-arm, dose-escalation, investigator-initiated clinical trial on a database.</jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>Setting</jats:title>
    <jats:p>Kyushu University Hospital, Kurume University Hospital, and related facilities.</jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>Patients</jats:title>
    <jats:p>Sixteen patients with inoperable or recurrent CS and ACS, with mildly impaired glucose tolerance.</jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>Intervention</jats:title>
    <jats:p>Oral administration of 200 mg S-707106 after dinner, daily, for 24 weeks. In patients with insufficient improvement in oral glucose tolerance test results at 12 weeks, an escalated dose of S-707106 (200 mg twice daily) was administered for the residual 12 weeks.</jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>Main Outcome Measures</jats:title>
    <jats:p>The rate of participants responding to glucose tolerance impairment, defined as those showing a 25% reduction in the area under the curve (AUC) of plasma glucose during the 75-g oral glucose tolerance test at 24 weeks.</jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>Results</jats:title>
    <jats:p>S-707106 administration could not achieve the primary endpoint of this clinical trial (>20% of responsive participants). AUC glucose decreased by −7.1% [SD, 14.8 (90% CI −14.8 to −1.0), P = 0.033] and −2.7% [14.5 (−10.2 to 3.4), P = 0.18] at 12 and 24 weeks, respectively. S-707106 administration decreased AUC glucose significantly in participants with a high body mass index. Body fat percentage decreased by −2.5% [1.7 (−3.3 to −1.8), P < 0.001] and body muscle percentage increased by 2.4% [1.6 (1.7 to 3.1), P < 0.001].</jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>Conclusions</jats:title>
    <jats:p>S-707106 is an effective insulin sensitizer and antisarcopenic and antiobesity medication for these patients.</jats:p>
    </jats:sec>

    DOI: 10.1210/clinem/dgab450

  • An open-label phase Ⅰ/Ⅱ a clinical trial of 11β-HSD1 inhibitor for Cushing's syndrome and autonomous cortisol secretion Reviewed International journal

    Satoko Oda, Kenji Ashida, Makiko Uchiyama, Shohei Sakamoto, Nao Hasuzawa, Ayako Nagayama, Lixiang Wang, Hiromi Nagata, Ryuichi Sakamoto, Junji Kishimoto, Koji Todaka, Yoshihiro Ogawa, Yoichi Nakanishi, Masatoshi Nomura,

    J Clin Endocrinol Metab.   2021.7

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    DOI: 10.1210/clinem/dgab450.

  • Study protocol for a multicentre, open-label, single-arm phase I/II trial to evaluate the safety and efficacy of ripasudil 0.4% eye drops for retinopathy of prematurity

    Mitsuru Arima, Hirosuke Inoue, Shintaro Nakao, Akiko Misumi, Maya Suzuki, Itsuka Matsushita, Shunsuke Araki, Chiemi Yamashiro, Kazumasa Takahashi, Masayuki Ochiai, Noriko Yoshida, Masayuki Hirose, Junji Kishimoto, Koji Todaka, Shunji Hasegawa, Kazuhiro Kimura, Koichi Kusuhara, Hiroyuki Kondo, Shouichi Ohga, Koh-Hei Sonoda

    BMJ Open   11 ( 7 )   2021.7

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    <jats:sec><jats:title>Introduction</jats:title><jats:p>Retinopathy of prematurity (ROP) is a vascular proliferative disorder that occurs in preterm infants. Existing treatments are only indicated in severe ROP cases due to the high invasiveness and the potential risk of irreversible side effects. We previously elucidated that ripasudil, a selective inhibitor of the Rho-associated protein kinase, has the ability to inhibit abnormal retinal neovascularisation in animal models. In addition, ripasudil eye drops (Glanatec ophthalmic solution 0.4%) have been already used for the treatment of glaucoma. Since eye drop therapy is less invasive, early intervention for ROP is possible. The purpose of this phase I/II trial is to evaluate the safety and efficacy of ripasudil eye drops for preterm infants with ROP.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>This is a multicentre, open-label, single-arm phase I/II trial. To evaluate the safety and efficacy of ripasudil as much as possible, ripasudil will be administered to all enrolled preterm infants with zone I/II, stage 1, or worse ROP. The safety and efficacy of ripasudil in treated patients will be assessed in comparison to a historical control group. Because this is the first trial of ripasudil in preterm infants, a dose-escalation study (once daily for 1 week, then two times per day for 2 weeks) will be conducted in phase I. After obtaining approval from the independent data and safety monitoring board to continue the trial after the completion of phase I, phase II will be conducted. In phase II, ripasudil eye drops will be administered two times per day for 12 weeks. The primary endpoint in phase II is also safety. Efficacy and pharmacokinetics will be evaluated as secondary endpoints.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>This study protocol was approved by the institutional review board at each of the participating centres. Data will be presented at international conferences and published in peer-reviewed journals.</jats:p></jats:sec><jats:sec><jats:title>Trial registration numbers</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results" xlink:href="NCT04621136">NCT04621136</jats:ext-link> and jRCT2071200047.</jats:p></jats:sec>

    DOI: 10.1136/bmjopen-2020-047003

  • Study protocol for a multicentre, open-label, single-arm phase I/II trial to evaluate the safety and efficacy of ripasudil 0.4% eye drops for retinopathy of prematurity. Reviewed International journal

    Arima M, Inoue H, Nakao S, Misumi A, Suzuki M, Matsushita I, Araki S, Yamashiro C, Takahashi K, Ochiai M, Yoshida N, Hirose M, Kishimoto J, Todaka K, Hasegawa S, Kimura K, Kusuhara K, Kondo H, Ohga S, Sonoda K.

    BMJ Open.   11 ( 7 )   e047003   2021.7

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    DOI: 10.1136/bmjopen-2020-047003.

  • 研究者主導臨床試験に望まれる安全性情報の取扱いについて Reviewed International journal

    高尾結佳,角田千穂,木村真紀,戸高浩司

    臨床薬理   52 ( 1 )   13 - 20   2021.1

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    Safety Information Management of Investigator-initiated Clinical Trials in Japan

  • Safety information management in investigator-initiated trials in Japan

    Yuka Takao, Chiho Tsunoda, Maki Kimura, Koji Todaka

    Japanese Journal of Clinical Pharmacology and Therapeutics   52 ( 1 )   13 - 19   2021.1

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    Timely reporting and appropriate response to safety information related to ongoing clinical trials is crucial for conducting trials appropriately and safely. However, it is difficult to understand exactly what, when, and to whom information should be reported because there are different types of clinical trials in Japan, governed by different laws and regulations. For example, principal investigators need to report serious, unrelated adverse events in "Chiken"clinical trials, but not in clinical trials specified under the Clinical Trials Act 2017. This paper clarifies the principal investigator's responsibility for reporting under the three laws related to clinical trials: the Pharmaceuticals and Medical Devices Act, the Clinical Trials Act, and the Act on the Safety of Regenerative Medicine. Report items were explained and summarized in a table. The paper also separately covers trials under other frameworks, such as the Ethical Guidelines for Medical and Health Research Involving Human Subjects. The paper will therefore help principal investigators to better understand their responsibilities and manage safety information in clinical trials under various frameworks in Japan. The paper also discusses some current issues that still need resolving.

    DOI: 10.3999/JSCPT.52.13

  • Safety and efficacy of brilliant blue g250 (BBG) for lens capsular staining: a phase III physician-initiated multicenter clinical trial

    Toshio Hisatomi, Hiroshi Enaida, Shigeo Yoshida, Akito Hirakata, Masahito Ohji, Kohji Nishida, Toshiaki Kubota, Nahoko Ogata, Takaaki Matsui, Kazuhiro Kimura, Koh-Hei Sonoda, Makiko Uchiyama, Junji Kishimoto, Koji Todaka, Yoichi Nakanishi, Tatsuro Ishibashi

    Japanese Journal of Ophthalmology   64 ( 5 )   455 - 461   2020.9

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    Purpose: To evaluate the safety and efficacy of BBG (Brilliant Blue G250) for lens capsular staining during cataract surgery with continuous curvilinear capsulorhexis. Study design: Prospective clinical study. Methods: This clinical trial enrolled 30 eyes of 30 patients who underwent cataract surgery with BBG (0.25 mg/mL Brilliant Blue G250) for capsular staining. Visualization of the lens capsule and the ease of capsulorhexis with BBG staining were evaluated in five grades (grade 0 to 4) by the Independent Data Monitoring Committee and the surgeons. The safety of BBG was also evaluated in terms of ocular and systemic tolerance for 7 days after surgery. Results: The use of BBG improved visualization of the lens capsule and complete capsulorhexis was performed in all patients. The major endpoint (Independent Data Monitoring Committee evaluation) showed that use of BBG improved visualization of the lens capsule and the ease of capsulorhexis (grades 2 to 4); the committee’s grading results were similar to those of the surgeons. Frequent complications observed in more than two eyes were conjunctival injection, corneal edema and intraocular pressure elevation. No severe complications were observed in ocular and systemic evaluations. Conclusion: BBG staining contributed to improved visualization of the lens capsule and aided in the completion of capsulorhexis during cataract surgery. The use of BBG for capsular staining also exhibited favorable safety results.

    DOI: 10.1007/s10384-020-00763-y

  • Safety and efficacy of brilliant blue g250 (BBG) for lens capsular staining: a phase III physician-initiated multicenter clinical trial. Reviewed International journal

    Hisatomi T, Enaida H, Yoshida S, Hirakata A, Ohji M, Nishida K, Kubota T, Ogata N, Matsui T, Kimura K, Sonoda KH, Uchiyama M, Kishimoto J, Todaka K, Nakanishi Y, Ishibashi T

    Jpn J Ophthalmol.   64 ( 5 )   455 - 461   2020.5

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  • Current progress and issues of cancer genomic medicine in Kyushu University Hospital

    Mamoru Ito, Hitomi Kawaji, Makoto Kubo, Eiji Oki, Eiji Iwama, Takahiro Maeda, Masanobu Ogawa, Masayuki Ochiai, Sawako Shikada, Hidetaka Yamamoto, Maya Suzuki, Koji Todaka, Naoki Nakashima, Minako Yoshihara, Mikita Suyama, Eishi Baba, Koichi Akashi, Yoichi Nakanishi

    ANNALS OF ONCOLOGY   30   2019.10

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    DOI: 10.1093/annonc/mdz343.086

  • Heterogeneous impact of body mass index on in-hospital mortality in acute heart failure syndromes: An analysis from the ATTEND Registry

    Akiomi Yoshihisa, Takamasa Sato, Katsuya Kajimoto, Naoki Sato, Yasuchika Takeishi, Kuniya Asai, Ryo Munakata, Toshiyuki Aokage, Asuka Yoshida, Yuichiro Minami, Dai Yumino, Masayuki Mizuno, Erisa Kawada, Kentaro Yoshida, Yuri Ozaki, Tomohito Kogure, Shintaro Haruki, Koichi Nakao, Tadashi Sawamura, Toshiaki Nuki, Ryoji Ishiki, Shigeki Yokota, Hiroyuki Fujinaga, Takashi Yamamoto, Kenji Harada, Akihiro Saito, Norihito Kageyama, Takanobu Okumura, Noritake Hata, Koji Murai, Ayaka Nozaki, Hidekazu Kawanaka, Jun Tanabe, Yukihito Sato, Katsuhisa Ishii, Hitoshi Oiwa, Tomoaki Matsumoto, Daisuke Yoshida, Nobuo Kato, Hitoshi Oiwa, Daisuke Yoshida, Nobuo Kato, Hiroshi Suzuki, Nobuyuki Shimizu, Takehiko Keida, Masaki Fujita, Kentaro Nakamura, Toshiya Chinen, Kentaro Meguro, Tatsuro Kikuchi, Toshiyuki Nishikido, Marohito Nakata, Tatsuya Yamashita, Masaya Nakata, Akitoshi Hirono, Kazuaki Mitsudo, Kazushige Kadota, Noriko Makita, Nagisa Watanabe, Masaaki Kawabata, Kenichi Fuji, Shinichi Okuda, Shigeki Kobayashi, Ikuo Moriuchi, Kiyo-O Mizuno, Kazuo Osato, Tatsuaki Murakami, Yoshifumi Shimada, Katsushi Misawa, Hiromasa Kokado, Takashi Fujita, Yoshitomo Fukuoka, Syu Takabatake, Yoshifumi Takata, Manabu Miyagi, Nobuhiro Tanaka, Akira Yamashina, Shinji Sudo, Koichi Shimamura, Michitaka Nagashima, Tomoya Kaneda, Kosei Ueda, Hiromasa Kato, Toshinori Higashikata, Kanichi Fujimori, Hiroshi Kobayashi, Shinya Fujii, Masahiro Yagi, Jyunko Takaki, Eiji Yamashita, Takuji Toyama, Etsuo Hirata, Kazuho Kamisihima, Toshiaki Oka, Ryushi Komatsu, Akira Itoh, Takahiko Naruko, Yukio Abe, Eiichirou Nakagawa, Atsuko Furukawa, Naoto Kinou, Shoko Uematsu, Isao Tabuchi, Taku Imai, Takafumi Sakamoto, Koji Todaka, Yuji Koide, Koji Maemura, Koichiro Yoshioka, Akiomi Yoshihisa, Takamasa Sato, Yasuchika Takeish, Toshiaki Ebina, Kazuo Kimura, Masaaki Konishi, Masahiko Kato, Yoshiharu Kinugasa, Katsunori Ishida, Shinobu Sugihara, Kiyotaka Yanagihara, Toshiharu Takeuchi, Motoi Okada, Naoyuki Hasebe, Tetsuo Sakai, Taku Asano, Yoshino Minoura, Tsutomu Toshida, Takatoshi Sato, Yuya Yokota, Seita Kondo, Yasushi Sakata, Issei Komuro, Kinya Otsu, Shizuya Yamashita, Yoshihiro Asano, Atsuya Kajimoto, Kazunori Kashiwase, Yasunori Ueda, Aizo Kondo, Katsuhiro Kawaguchi, Akinori Sawamura, Taro Saito, Tom Higa, Hiroo Noguchi, Yoko Yanagita, Keita Nakamura, Tomo Komaki, Oshihiro Muramatsu, Tomomi Koizumi, Yoshie Nakajima, Toshihiko Kikutani, Yoshifimi Ikeda, Tom Tamaki, Shuhei Funada, Harumi Ogawa, Koichiro Sakuragawa, Shun Kohsaka, Shin-ichi Ando, Toshiaki Kadokami, Eiko Ishida, Katsumi Ide, Yohei Sotomi, Yoshiharu Higuchi, Motoko Uehara, Toshihiko Goto, Nobuyuki Ohte, Masanobu Miura, Nobuyuki Shiba, Kotaro Nochioka, Hiroaki Shimokawa, Shiro Ishihara, Tokushi Koga, Shinichiro Fujishima, Shigeru Kaseda, Yoshie Haga, Keisuke Kida, Kazuho Kamisihima, Makiko Nakamura, Osahiko Sunagawa, Takafumi Miyara, Youji Taba, Takashi Touma, Osamu Shinjo, Oshioki Nishimura, Kazuomi Kario, Hayato Shimizu, Takahiro Uchida, Ken-ichi Amitani, Katsunori Shimada

    EUROPEAN HEART JOURNAL-ACUTE CARDIOVASCULAR CARE   8 ( 7 )   589 - 598   2019.10

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    Background: Although the obesity paradox may vary depending upon clinical background factors such as age, gender, aetiology of heart failure and comorbidities, the reasons underlying the heterogeneous impact of body mass index (BMI) on in-hospital cardiac mortality under various conditions in patients with acute heart failure syndromes (AHFSs) remain unclear. Methods: Among 4617 hospitalised patients with AHFSs enrolled in the Acute Decompensated Heart Failure Syndromes (ATTEND) registry, the patient characteristics and in-hospital cardiac mortality rates in those with low BMI (BMI <25 kg/m(2), n = 3263) were compared to those with high BMI (BMI > 25 kg/m(2), n = 1354). Results: Compared to the high-BMI group, the low-BMI group was significantly older, less likely to be male and to have hypertensive or idiopathic dilated aetiologies and more likely to have valvular aetiologies and a history of prior hospitalisation for AHFS. The low-BMI group also had lower prevalence rates of diabetes, dyslipidaemia, hypertension and atrial fibrillation and higher prevalence rates of anaemia and chronic obstructive pulmonary disease. In addition, cardiac mortality was significantly higher in the low-BMI group than in the high-BMI group (5.5 vs. 1.5%, p < 0.001). Logistic regression analysis demonstrated that low BMI was a predictor of cardiac mortality (odds ratio: 3.89, 95% confidence interval: 2.44-6.21). In subgroup analyses, the impact of BMI on cardiac mortality differed depending on the presence of hypertensive aetiology, hypertension, chronic obstructive pulmonary disease and hyponatremia (all p < 0.05), although there were no interactions between the impacts of BMI and age, gender, other aetiologies, prior hospitalisation, diabetes, anaemia, cardio-renal function and in-hospital management. Conclusion: It is necessary to appreciate the obesity paradox in AHFS patients, and a patient's heterogeneous background should also be considered.

    DOI: 10.1177/2048872617703061

  • Investigator initiated clinical trial of cancer vaccine OCV-C01 in advanced and recurrent biliary tract cancer

    Mutsunori Murahashi, Hisanobu Ogata, Toshihiko Okazaki, Yasuki Hijikata, Kazunari Yamada, Toshihisa Tsuruta, Junji Kishimoto, Kouta Funakoshi, Koji Todaka, Yoichi Nakanishi, Kenzaburo Tani

    ANNALS OF ONCOLOGY   29   2018.10

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  • Power Spectral Analysis of Short-Term Blood Pressure Recordings for Assessing Daily Variations of Blood Pressure in Human

    Hiroyuki Kinoshita, Hiroshi Mannoji, Keita Saku, Jumpei Mano, Tadayoshi Miyamoto, Koji Todaka, Takuya Kishi, Shigehiko Kanaya, Kenji Sunagawa

    Proceedings of the Annual International Conference of the IEEE Engineering in Medicine and Biology Society, EMBS   2018-July   3626 - 3629   2018.10

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    Although daily variations of blood pressure (BP) predict cardiovascular event risk, their assessment requires ambulatory BP monitoring which hinders the clinical application of this approach. Since the baroreflex is a major determinant of BP variations, especially in the frequency range of 0.01-0.1 Hz (baro-frequency), we hypothesized that the power spectral density (PSD) of short-term BP recordings in the baro-frequency range may predict daily variations of BP. In nine-week-old Wister-Kyoto male rats (N =5) with or without baroreflex dysfunction, we telemetrically recorded continuous BP for 24 hours and estimated PSD using Welch's periodogram for the recordings during the 12-hour light period. We compared the reference PSD of 12-hour recording with the PSDs obtained from shorter data lengths ranging from 5 to 240 minutes. The 30-minute BP recordings reproduced PSD of 12-hour recordingswell, and PSD in the baro-frequency range paralleled the standard deviation of 12-hour BP. Thus, the PSD of 30-minute BP reflects the daily BP variability in rats. In human subjects, we estimated PSD from 30-minute noninvasive continuous BP recordings. The rat and human PSDs shared remarkably similar characteristics. Furthermore, comparison of PSD between elderly and young subjects suggested that the baro-frequency range in humans overlapped with that in rats. In conclusion, PSD derived from 30-minute BP recordings is capable of predicting daily BP variations. Our proposed method may serve as a simple, noninvasive and practical tool for predicting cardiovascular events in the clinical setting.

    DOI: 10.1109/EMBC.2018.8513040

  • Safety, Tolerability, and Pharmacokinetics of NK-104-NP

    Kaku Nakano, Tetsuya Matoba, Jun-ichiro Koga, Yushi Kashihara, Masato Fukae, Ichiro Ieiri, Masanari Shiramoto, Shin Irie, Junji Kishimoto, Koji Todaka, Kensuke Egashira

    International Heart Journal   59 ( 5 )   1015 - 1025   2018.9

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    Pulmonary hypertension (PH) is a disease with poor prognosis, caused by the obstruction/stenosis of small pulmonary arteries. Statin is known to have vasodilating and anti-inflammatory property and is considered to be a candidate of therapeutic agents for the treatment of PH, but its efficacy has not been verified in clinical trials. We have formulated pitavastatin incorporating nanoparticles composed of poly (lactic-co-glycolic acid) (NK-104-NP) to improve drug delivery to the pulmonary arteries and evaluated their safety and pharmacokinetics in healthy volunteers. To accomplish this purpose, phase I clinical trials were conducted. In the single intravenous administration regimen, 40 healthy subjects were enrolled and PK (pharmacokinetic) parameters in 4 groups (1, 2, 4, and 8 mg as pitavastatin calcium) were as follows: 1.00 hour after the administration, the plasma concentration of pitavastatin reached Cmax (the maximum drug concentration) in all groups. Cmax, AUC0-t (area under the curve from time 0 to the last measurable concentration) and AUC0-∞ (area under the curve from time 0 extrapolated to infinite time) were increased in a dose-dependent manner. Population pharmacokinetic analysis based on these results indicated no accumulation of pitavastatin after repeated administration of NK-104-NP for 7 days. In this 7-day administration trial, the mean Cmax and AUC0-∞ of pitavastatin were not significantly different between days 1 and 7, suggesting that pitavastatin is unlikely to accumulate after repeated administration. In these trials, three adverse events (AEs) were reported, but they were resolved without any complications and judged to have no causal relationships with NK-104-NP. These results indicate that the innovative nanotechnology-based medicine NK-104-NP exhibited dose-dependent pharmacokinetics and was well tolerated with no significant AEs in healthy volunteers.

    DOI: 10.1536/ihj.17-555

  • Impact of Risk-Benefit Perception and Trust on Medical Technology Acceptance in Relation to Drug and Device Lag: A Tripartite Cross-Sectional Survey International journal

    Koji Todaka, Junji Kishimoto, Masayuki Ikeda, Koji Ikeda, Haruko Yamamoto

    Therapeutic Innovation & Regulatory Science   52 ( 5 )   629 - 640   2018.9

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    BACKGROUND: New drug and medical device introduction in Japan usually lags behind that in the West. Many reports indicate that in Japan, the associated risks are considered greater than the benefits recognized in other countries. This study aimed to compare the relationship between risk-benefit perception and acceptance of medical technologies in 3 leading markets. METHODS: A tripartite cross-sectional survey of the general public was used. In total, 3345 adults in the United Kingdom, the United States, and Japan participated, and sexes and age groups were equally represented. Questions about the perception of risk, benefit, and acceptance of medical and other scientific technologies, and trust of medical product providers or regulatory authorities were included. RESULTS: Five-step Likert coding for risk/benefit/acceptance of 4 medical items (x-rays, antibiotics, vaccines, and cardiac pacemakers) and 6 general items (such as automobiles and airplanes) were collected. Relationships between benefit perception and acceptance were linear for 4 medical technologies. The relationship had a similar slope but was shifted downward in Japan compared with the UK and US ( P < .01), suggesting a lower acceptance in Japan for all benefit perceptions. The trend was the same between risk perception and acceptance, except for slopes that were negative. Correspondence analysis showed a strong correlation among acceptance of medical technologies, benefits of medical technologies, trust in doctors, and trust in the Department of Health. The UK and US attributes were clustered with positive responses such as "useful," "acceptable," and "trustworthy," whereas Japan was clustered with intermediate to negative responses such as "neither" and "untrustworthy." CONCLUSIONS: Acceptance of medical technologies was low in Japan because of significant differences in trust for doctors and authorities compared with that in the UK and US. This is a possible basis for delays of 24 to 60 months for medical product approval in Japan.

    DOI: 10.1177/2168479017739267

  • Safety, Tolerability, and Pharmacokinetics of NK-104-NP. Reviewed International journal

    Nakano K, Matoba T, Koga JI, Kashihara Y, Fukae M, Ieiri I, Shiramoto M, Irie S, Kishimoto J, Todaka K, Egashira K.

    Int Heart J   59 ( 5 )   1015 - 1025   2018.9

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    DOI: 10.1536/ihj.17-555

  • Power Spectral Analysis of Short-Term Blood Pressure Recordings for Assessing Daily Variations of Blood Pressure in Human Reviewed International journal

    Hiroyuki Kinoshita, Hiroshi Mannoji, Keita Saku, Jumpei Mano, Tadayoshi Miyamoto Koji Todaka, Takuya Kishi, Shigehiko Kanaya, and Kenji Sunagawa

    Conf Proc IEEE Eng Med Biol Soc.   2018   3626 - 3629   2018.7

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    Although daily variations of blood pressure (BP) predict cardiovascular event risk, their assessment requires ambulatory BP monitoring which hinders the clinical application of this approach. Since the baroreflex is a major determinant of BP variations, especially in the frequency range of 0.01-0.1 Hz (baro-frequency), we hypothesized that the power spectral density (PSD) of short-term BP recordings in the baro-frequency range may predict daily variations of BP. In nine-week-old Wister-Kyoto male rats (N = 5) with or without baroreflex dysfunction, we telemetrically recorded continuous BP for 24 hours and estimated PSD using Welch's periodogram for the recordings during the 12-hour light period. We compared the reference PSD of 12-hour recording with the PSDs obtained from shorter data lengths ranging from 5 to 240 minutes. The 30-minute BP recordings reproduced PSD of 12-hour recordings well, and PSD in the baro-frequency range paralleled the standard deviation of 12-hour BP. Thus, the PSD of 30-minute BP reflects the daily BP variability in rats. In human subjects, we estimated PSD from 30-minute noninvasive continuous BP recordings. The rat and human PSDs shared remarkably similar characteristics. Furthermore, comparison of PSD between elderly and young subjects suggested that the baro-frequency range in humans overlapped with that in rats. In conclusion, PSD derived from 30-minute BP recordings is capable of predicting daily BP variations. Our proposed method may serve as a simple, noninvasive and practical tool for predicting cardiovascular events in the clinical setting.

    DOI: 10.1109/EMBC.2018.8513040

  • Ischemic or Nonischemic Functional Mitral Regurgitation and Outcomes in Patients With Acute Decompensated Heart Failure With Preserved or Reduced Ejection Fraction

    Katsuya Kajimoto, Yuichiro Minami, Shigeru Otsubo, Naoki Sato, Naoki Sato, Kuniya Asai, Ryo Munakata, Toshiyuki Aokage, Asuka Yoshida, Yuichiro Minami, Dai Yumino, Masayuki Mizuno, Erisa Kawada, Kentaro Yoshida, Yuri Ozaki, Tomohito Kogure, Shintaro Haruki, Masayuki Mizuno, Katsuya Kajimoto, Koichi Nakao, Tadashi Sawamura, Toshiaki Nuki, Ryoji Ishiki, Shigeki Yokota, Hiroyuki Fujinaga, Takashi Yamamoto, Kenji Harada, Akihiro Saito, Norihito Kageyama, Takanobu Okumura, Noritake Hata, Koji Murai, Ayaka Nozaki, Hidekazu Kawanaka, Jun Tanabe, Yukihito Sato, Katsuhisa Ishii, Hitoshi Oiwa, Tomoaki Matsumoto, Daisuke Yoshida, Nobuo Kato, Hiroshi Suzuki, Nobuyuki Shimizu, Takehiko Keida, Masaki Fujita, Kentaro Nakamura, Toshiya Chinen, Kentaro Meguro, Tatsuro Kikuchi, Toshiyuki Nishikido, Marohito Nakata, Tatsuya Yamashita, Masaya Nakata, Akitoshi Hirono, Kazuaki Mitsudo, Kazushige Kadota, Noriko Makita, Nagisa Watanabe, Masaaki Kawabata, Kenichi Fujii, Shinichi Okuda, Shigeki Kobayashi, Ikuo Moriuchi, Kiyo o. Mizuno, Kazuo Osato, Tatsuaki Murakami, Yoshifumi Shimada, Katsushi Misawa, Hiromasa Kokado, Takashi Fujita, Yoshitomo Fukuoka, Syu Takabatake, Yoshifumi Takata, Manabu Miyagi, Nobuhiro Tanaka, Akira Yamashina, Shinji Sudo, Koichi Shimamura, Michitaka Nagashima, Tomoya Kaneda, Kosei Ueda, Hiromasa Kato, Toshinori Higashikata, Kanichi Fujimori, Hiroshi Kobayashi, Shinya Fujii, Masahiro Yagi, Yuri Ozaki, Jyunko Takaki, Eiji Yamashita, Takuji Toyama, Tetsuo Hirata, Kazuho Kamisihima, Toshiaki Oka, Ryushi Komatsu, Akira Itoh, Takahiko Naruko, Yukio Abe, Eiichirou Nakagawa, Atsuko Furukawa

    American Journal of Cardiology   120 ( 5 )   809 - 816   2017.9

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    The aim of this study was to evaluate the association of functional mitral regurgitation (FMR), preserved or reduced ejection fraction (EF), and ischemic or nonischemic origin with outcomes in patients discharged alive after hospitalization for acute decompensated heart failure (HF). Of the 4,842 patients enrolled in the Acute Decompensated Heart Failure Syndromes (ATTEND) registry, 3,357 patients were evaluated to assess the association of FMR, preserved or reduced EF, and ischemic or nonischemic origin with the primary end point (all-cause death and readmission for HF after discharge). At the time of discharge, FMR was assessed semiquantitatively (classified as none, mild, or moderate to severe) by color Doppler analysis of the regurgitant jet area. According to multivariable analysis, in the ischemic group, either mild or moderate to severe FMR in patients with a preserved EF had a significantly higher risk of the primary end point than patients without FMR (hazard ratio [HR] 1.60; 95% confidence interval [CI] 1.12 to 2.29; p = 0.010 and HR 1.98; 95% CI 1.30 to 3.01; p = 0.001, respectively). In patients with reduced EF with an ischemic origin, only moderate to severe FMR was associated with a significantly higher risk of the primary end point (HR 1.67; 95% CI 1.11 to 2.50; p = 0.014). In the nonischemic group, there was no significant association between FMR and the primary end point in patients with either a preserved or reduced EF. In conclusion, among patients with acute decompensated HF with a preserved or reduced EF, the association of FMR with adverse outcomes may differ between patients who had an ischemic or nonischemic origin of HF.

    DOI: 10.1016/j.amjcard.2017.05.051

  • The challenge of magnetic vagal nerve stimulation for myocardial infarction -preliminary clinical trial International journal

    Takuya Nishikawa, Keita Saku, Koji Todaka, Yukimitsu Kuwabara, Shinobu Arai, Takuya Kishi, Tomomi Ide, Hiroyuki Tsutsui, Kenji Sunagawa

    Proceedings of the Annual International Conference of the IEEE Engineering in Medicine and Biology Society, EMBS   2017   4321 - 4324   2017.9

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    Numerous studies have shown in animal models that vagal nerve stimulation (VNS) strikingly reduces infarct size of acute myocardial infarction (AMI) and prevents heart failure. However, the lack of techniques to noninvasively stimulate the vagal nerve hinders VNS from clinical applications. Transcranial magnetic stimulation is noninvasive and capable of stimulating central neurons in patients. In this study, we examined whether the magnetic stimulation could noninvasively activate the cervical vagal nerve in healthy human. Sixteen healthy males and 4 females were enrolled in this study. We used Magstim Rapid2 with a 70-mm double coil in the right neck. We randomly assigned the subjects to 5 Hz or 20 Hz stimulation. We defined the maximum intensity of stimulation (MAX) which is the intensity just below the threshold of adverse effects. We defined HALF as a half of MAX. Protocols comprised 2 sets of MAX and 2 sets of HALF. Each stimulation continued for 3 minutes. We monitored heart rate (HR) and assessed the bradycardic response as an index of successful VNS. Nineteen subjects completed all protocols. They had no problematic adverse events during and/or after magnetic VNS. The magnetic VNS induced transient bradycardic responses in some subjects, whereas failed to induce sustained bradycardia in pooled data in any settings. Arterial pressure did not change either. Successful magnetic stimulation requires technical improvements including narrowing the magnetic focus and optimization of stimulation site. These improvements may enable us to apply magnetic VNS in the management of AMI.

    DOI: 10.1109/EMBC.2017.8037812

  • Safety, Tolerability, and Preliminary Efficacy of the Anti-Fibrotic Small Molecule PRI-724, a CBP/β-Catenin Inhibitor, in Patients with Hepatitis C Virus-related Cirrhosis: A Single-Center, Open-Label, Dose Escalation Phase 1 Trial

    Kiminori Kimura, Akemi Ikoma, Maki Shibakawa, Shinji Shimoda, Kenichi Harada, Masanao Saio, Jun Imamura, Yosuke Osawa, Masamichi Kimura, Koji Nishikawa, Takuji Okusaka, Satoshi Morita, Kazuaki Inoue, Tatsuya Kanto, Koji Todaka, Yoichi Nakanishi, Michinori Kohara, Masashi Mizokami

    EBioMedicine   23   79 - 87   2017.9

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    Background There is currently no anti-fibrotic drug therapy available to treat hepatitis C virus (HCV) cirrhosis. The aim of this study was to assess the safety, tolerability, and anti-fibrotic effect of PRI-724, a small-molecule modulator of Wnt signaling, in patients with HCV cirrhosis. Methods In this single-center, open-label, phase 1 trial, we sequentially enrolled patients with HCV cirrhosis who were classified as Child-Pugh (CP) class A or B. PRI-724 was administered as a continuous intravenous infusion of 10, 40, or 160 mg/m2/day for six cycles of 1 week on and 1 week off. The primary endpoints were frequency and severity of adverse events. The secondary endpoint was efficacy of PRI-724 in treating cirrhosis based on CP score and liver biopsy. This study is registered with ClinicalTrials.gov (no. NCT02195440). Findings Between Sept 3, 2014 and May 2, 2016, 14 patients were enrolled: CP class A:B, 6:8; median age, 62 (range: 43 to 74) years; male:female, 10:4. Twelve of the 14 patients completed six cycles of treatment; one was withdrawn from the study due to possible study drug-related liver injury (grade 3) in the 160 mg/m2/day dose cohort and one withdrew for personal reasons. Serious adverse events occurred in three patients [21% (3/14)], one of which was possibly related to PRI-724. The most common adverse events were nausea [29% (4/14)] and fatigue [21% (3/14)]. After PRI-724 administration, the CP scores worsened by 1 point in two patients in the 10 mg/m2/day cohort, improved in three patients at 1, 1, and 2 points in the 40 mg/m2/day cohort, and improved in one patient by 3 points in the 160 mg/m2/day cohort. The histology activity index scores of the liver tissue improved in two patients and exacerbated in two patients in the 10 mg/m2/day cohort, and improved in one patient in the 40 mg/m2/day cohort. Interpretation This study showed that administration of 10 or 40 mg/m2/day intravenous PRI-724 over 12 weeks was well-tolerated by patients with HCV cirrhosis; however, liver injury as a possible related serious adverse event was observed in the 160 mg/m2/day cohort. Funding Source AMED.

    DOI: 10.1016/j.ebiom.2017.08.016

  • Ezetimibe in Combination With Statins Ameliorates Endothelial Dysfunction in Coronary Arteries After Stenting International journal

    Susumu Takase, Tetsuya Matoba, Soichi Nakashiro, Yasushi Mukai, Shujiro Inoue, Keiji Oi, Taiki Higo, Shunsuke Katsuki, Masao Takemoto, Nobuhiro Suematsu, Kenichi Eshima, Kenji Miyata, Mitsutaka Yamamoto, Makoto Usui, Kenji Sadamatsu, Shinji Satoh, Toshiaki Kadokami, Kiyoshi Hironaga, Ikuyo Ichi, Koji Todaka, Junji Kishimoto, Kensuke Egashira, Kenji Sunagawa

    Arteriosclerosis, Thrombosis, and Vascular Biology   37 ( 2 )   350 - 358   2017.2

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    <jats:sec>
    <jats:title>Objectives—</jats:title>
    <jats:p>We sought to investigate whether treatment with ezetimibe in combination with statins improves coronary endothelial function in target vessels in coronary artery disease patients after coronary stenting.</jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>Approach and Results—</jats:title>
    <jats:p>
    We conducted a multicenter, prospective, randomized, open-label, blinded-end point trial among 11 cardiovascular treatment centers. From 2011 to 2013, 260 coronary artery disease patients who underwent coronary stenting were randomly allocated to 2 arms (statin monotherapy, S versus ezetimibe [10 mg/d]+statin combinational therapy, E+S). We defined target vessel dysfunction as the primary composite outcome, which comprised target vessel failure during treatment and at the 6- to 8-month follow-up coronary angiography and coronary endothelial dysfunction determined via intracoronary acetylcholine testing performed in cases without target vessel failure at the follow-up coronary angiography. Coadministration of ezetimibe with statins further lowered low-density lipoprotein cholesterol levels (83±23 mg/dL in S versus 67±23 mg/dL in E+S;
    <jats:italic>P</jats:italic>
    <0.0001), with significant decreases in oxidized low-density lipoprotein and oxysterol levels. Among patients without target vessel failure, 46 out of 89 patients (52%) in the S arm and 34 out of 96 patients (35%) in the E+S arm were found to have coronary endothelial dysfunction (
    <jats:italic>P</jats:italic>
    =0.0256), and the incidence of target vessel dysfunction at follow-up was significantly decreased in the E+S arm (69/112 (62%) in S versus 47/109 (43%) in E+S;
    <jats:italic>P</jats:italic>
    =0.0059). A post hoc analysis of post-treatment low-density lipoprotein cholesterol–matched subgroups revealed that the incidence of both target vessel dysfunction and coronary endothelial dysfunction significantly decreased in the E+S arm, with significant reductions in oxysterol levels.
    </jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>Conclusions—</jats:title>
    <jats:p>The CuVIC trial (Effect of Cholesterol Absorption Inhibitor Usage on Target Vessel Dysfunction after Coronary Stenting) has shown that ezetimibe with statins, compared with statin monotherapy, improves functional prognoses, ameliorating endothelial dysfunction in stented coronary arteries, and was associated with larger decreases in oxysterol levels.</jats:p>
    </jats:sec>

    DOI: 10.1161/atvbaha.116.308388

  • Efficacy and Safety of A0001 (Brilliant Blue G250) for Internal Limiting Membrane Staining and Peeling: Phase III Investigator-initiated Multicenter Clinical Trial

    Hiroshi Enaida, Akito Hirakata, Masahito Ohji, Kohji Nishida, Toshiaki Kubota, Nahoko Ogata, Koh Hei Sonoda, Makiko Uchiyama, Junji Kishimoto, Koji Todaka, Yoichi Nakanishi, Tatsuro Ishibashi

    Nippon Ganka Gakkai zasshi   120 ( 6 )   439 - 448   2016.6

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    PURPOSE: To investigate the efficacy and safety of A0001 (brilliant blue G250) for visualization of the internal limiting membrane (ILM) during and after vitrectomy.

  • A0001(ブリリアントブルーG250)の内境界膜染色と剝離に対する有効性と安全性の検討―多施設共同第III相医師主導治験 Reviewed

    江内田 寛, 平形 明人, 大路 正人, 西田 幸二, 久保田 敏昭, 緒方 奈保子, 園田 康平, 内山 麻希子, 岸本 淳司, 戸高 浩司, 中西 洋一, 石橋 達朗

    日眼会誌   120 ( 6 )   439 - 448   2016.5

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  • 医療機器を用いた臨床研究実施に関するアンケート調査結果 Reviewed

    清水公治, 伊藤達也, 岩江荘介, 大守伊織, 倉田真由美, 住谷昌彦, 戸高 浩司, 村山敏典, 山本晴子, 川上浩司

    医療機器学   86 ( 5 )   482 - 488   2016.5

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  • イルベサルタン/トリクロルメチアジド配合錠(S-474474)の有効性と安全性の検討― 本態性高血圧症患者を対象とした多施設共同長期投与試験 Reviewed

    荻原 俊男, 戸高 浩司, 恋田 直子

    血圧   20 ( 8 )   101 - 115   2013.8

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  • Global cardiovascular device innovation: Japan-USA synergies - Harmonization by doing (HBD) program, a consortium of regulatory agencies, medical device industry, and academic institutions

    Takahiro Uchida, Fumiaki Ikeno, Koji Ikeda, Yuka Suzuki, Koji Todaka, Hiroyoshi Yokoi, Gary Thompson, Mitchel Krucoff, Shigeru Saito

    Circulation Journal   77 ( 7 )   1714 - 1718   2013.7

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    Background: Global medical devices have become more popular, but investment money for medical device development is not easily available in the market. Worldwide health-care budget constraints mean that efficient medical device development has become essential. To achieve efficient development, globalization is a key to success. Spending large amounts of money in different regions for medical device development is no longer feasible. Methods and Results: In order to streamline processes of global medical device development, an academic, governmental, and industrial consortium, called the Harmonization by Doing program, has been set up. The program has been operating between Japan and the USA since 2003. The program has 4 working groups: (1) Global Cardiovascular Device Trials; (2) Study on Post-Market Registry; (3) Clinical Trials; and (4) Infrastructure and Methodology Regulatory Convergence and Communication. Each working group has as its goals the achievement of speedy and efficient medical device development in Japan and the USA. The program has held multiple international meetings to deal with obstacles against efficient medical device development. Conclusions: This kind of program is very important to deliver novel medical devices. Involvement of physicians in this type of activity is also very helpful to achieve these goals.

    DOI: 10.1253/circj.CJ-12-1431

  • イルベサルタン/トリクロルメチアジド配合錠(S-474474)の有効性と安全性の検討― イルベサルタン 200 mg 配合剤の優越性検証試験 Reviewed

    荻原 俊男, 戸高 浩司, 恋田 直子

    血圧   20 ( 6 )   101 - 114   2013.6

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  • 「未承認医療機器を用いた臨床研究実施の手引き」抜粋版 Invited

    川上浩司, 中里適, 北川雄光, 清水公治, 田上和夫, 戸高 浩司, 松田公志, 山本晴子

    薬理と治療   40 ( (suppl-1) )   5048 - 5052   2012.3

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  • Overexpression of Mitochondria DNA Helicase, Twinkle, Ameliorates Cardiac Remodeling and Failure in Mice

    Takahiro Inoue, Tomomi Ide, Henna Tyynismaa, Masayoshi Yoshida, Makoto Ando, Atsushi Tanaka, Koji Todaka, Dongchon Kang, Anu Suomalainen, Kenji Sunagawa

    CIRCULATION   118 ( 18 )   S314 - S315   2008.10

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  • Transcutaneous Bionic Baroreflex System Is Widely Applicable For Preventing Severe Orthostatic Hypotension In Patients With Cervical Cord Injury

    Masayoshi Yoshida, Akiko Chishaki, Yoshinori Murayama, Satoshi Kimura, Makoto Ando, Toshirou Saito, Touru Shiino, Keiichiro Shiba, Koji Todaka, Kenji Sunagawa

    CIRCULATION   118 ( 18 )   S548 - S548   2008.10

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  • Do we need combination products? Invited

    Koji Todaka

    J Clin Therap Med(臨床医薬)   2006.1

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  • 日本の新薬開発は特殊なのか? Invited

    戸高浩司

    Jpn J Clin Pharmacol Ther (臨床薬理)   2006.1

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  • Review of Bridging Programs, Regulatory Successes Invited

    戸高浩司

    臨床評価   2004.1

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  • GRP:日本における薬剤開発のインフラとしての医師の役割 Invited

    戸高浩司

    臨床評価   2004.1

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  • Load dependence of ventricular performance explained by model of calcium-myofilament interactions

    Juichiro Shimizu, Koji Todaka, Daniel Burkhoff

    American Journal of Physiology - Heart and Circulatory Physiology   282 ( 3 51-3 )   2002.3

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    Although a simple concept of load-independent behavior of the intact heart evolved from early studies of isolated, intact blood-perfused hearts, more recent studies showed that, as in isolated muscle, the mode of contraction (isovolumic vs. ejection) impacts on end-systolic elastance. The purpose of the present study was to test whether a four-state model of myofilament interactions with length-dependent rate constants could explain the complex contractile behavior of the intact, ejecting heart. Studies were performed in isolated, blood-perfused canine hearts with intracellular calcium transients measured by macroinjected aequorin. Measured calcium transients were used as the driving function for the model, and length-dependent rate constants yielding the highest concordance between measured and model-predicted midwall stress at different isovolumic volumes were determined. These length-dependent rate constants successfully predicted contractile behavior on ejecting contractions. This, along with additional model analysis, suggests that length-dependent changes in calcium binding affinity may not be an important factor contributing to load-dependent contractile performance in the intact heart under physiological conditions.

    DOI: 10.1152/ajpheart.00498.2001

  • Total occlusion of inferior vena cava in a patient with antiphospholipid antibody syndrome associated with Behçet's disease

    Y. Mukai, H. Tsutsui, K. Todaka, M. Mohri, N. Hirai, H. Arai, A. Takeshita

    Japanese Circulation Journal   65 ( 9 )   837 - 838   2001.9

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    Behçet's disease frequently involves the venous system, usually affecting small vessels, but sometimes large vessels such as the vena cava. Antiphospholipid antibody syndrome is associated with an increased incidence of arterial and venous thrombosis. A 29-year-old male with Behçet's disease developed bilateral leg edema secondary to thrombotic occlusion of the inferior vena cava. Laboratory tests revealed positive antiphospholipid antibodies and lupus anticoagulant. Treatment with steroid and warfarin subsequent to intravenous administration of uro-kinase resulted in improvement of symptoms. The association of antiphospholipid antibody syndrome and Behçet's disease may have caused the total thrombotic occlusion of the vena cava in this case.

    DOI: 10.1253/jcj.65.837

  • Effect of BAY y 5959 on myocardial function and metabolism in normal and failing hearts

    Koji Todaka, Jie Wang, Geng Hua Yi, Anguo Gu, Shu Ming Zhu, Hui Zhang, Daniel Burkhoff

    American Journal of Physiology - Heart and Circulatory Physiology   274 ( 5 43-5 )   1998.5

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    BAY y 5959 is a dihydropyridine derivative with positive inotropic actions mediated by a direct increase in intracellular calcium. We characterized the direct myocardial actions of this new agent in hearts isolated from seven normal dogs and from five dogs with repeated coronary microembolization-induced heart failure. Inotropic actions of BAY y 5959 were accompanied by little effect on duration of contraction and by prolongation of the monophasic action potential (MAP); in contrast, isoproterenol decreased contraction and MAP durations. Whereas inotropic responsiveness to isoproterenol was blunted in embolized hearts, these actions of BAY y 5959 were relatively preserved in the heart failure state. Isoproterenol increased heart rate, whereas BAY y 5959 had little effect. Changes in coronary vascular resistance also decreased similarly for isoproterenol and BAY y 5959. Finally, for comparable inotropy, increases in myocardial oxygen consumption were similar for isoproterenol and for BAY y 5959. In summary, preserved inotropic responsiveness and lack of positive chronotropic actions are two clinically favorable features of this type of inotropic agents compared with a typical β-adrenergic agonist.

    DOI: 10.1152/ajpheart.1998.274.5.h1560

  • Effect of ventricular stretch on contractile strength, calcium transient, and cAMP in intact canine hearts

    Koji Todaka, Kazuhide Ogino, Anguo Gu, Daniel Burkhoff

    American Journal of Physiology - Heart and Circulatory Physiology   274 ( 3 43-3 )   1998.3

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    Isovolumic contractions were imposed by intraventricular balloon in 39 isolated, blood-perfused canine hearts to investigate the effects of myocardial stretch on contractile force. After stabilization at 37°C, left ventricular volume was increased so that end-diastolic pressure increased from 0 to 5 mmHg. After the immediate increase in developed pressure [DP; from 37 ± 14 to 82 ± 22 mmHg (means ± SD)], there was a slow secondary rise in DP (97 ± 27 mmHg) that peaked at 3 min. However, DP subsequently decreased over the next 7 min back to the initial value (84 ± 25 mmHg). Light emission from macroinjected aequorin (n = 10 hearts) showed that changes in intracellular calcium [3 min: 124 ± 15% (P < 0.01); 10 min: 99 ± 18% of baseline] paralleled DP changes. Increases in myocardial adenosine 3',5'-cyclic monophosphate (cAMP) content (n = 12) accompanied the secondary rise in DP. In contrast, the gradual elevation of DP after the stretch was not exerted during continuous [β-adrenergic stimulation by isoproterenol. Thus, in contrast to isolated muscle, stretch only transiently increases intracellular calcium and contractile strength in intact hearts. The findings of changes in cAMP and abolition of the phenomena by β-stimulation suggest that a primary stretch-mediated influence on cAMP metabolism may underlie these phenomena.

    DOI: 10.1152/ajpheart.1998.274.3.h990

  • Functional consequences of acute collagen degradation studied in crystalloid perfused rat hearts. International journal

    Todaka K, Jiang T, Chapman JT, Gu A, Zhu SM, Herzog E, Hochman JS, Steinberg SF, Burkhoff D

    Basic Research in Cardiology   1997.6

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  • Left-to-right systolic and diastolic ventricular interactions are dependent on right ventricular volume

    Marc L. Dickstein, Koji Todaka, Daniel Burkhoff

    American Journal of Physiology - Heart and Circulatory Physiology   272 ( 6 41-6 )   1997.6

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    Three-compartment elastance modeling predicts that the magnitude of gain is solely dependent on the ratio of free wall and septal elastances. However, when nonlinearities in pressure-volume relationships are considered, the same model predicts that gain is load dependent. We therefore studied left-to- right ventricular interactions in the isolated cross-perfused canine heart preparation to determine whether, in fact, right ventricular volume modulates left-to-right ventricular interaction. We found that left-to-right systolic gain increased from 0.035 ± 0.022 to 0.073 ± 0.017 (P = 0.003) and left- to-right diastolic gain increased from 0.067 ± 0.050 to 0.186 ± 0.097 (P = 0.03) in response to increased right ventricular volume. This degree of volume dependency of gain is predicted by the three-compartment model when measured nonlinearities in time-varying elastance are taken into account. Future studies will need to account for changes in loading conditions when interpreting changes in systolic and diastolic interactions.

    DOI: 10.1152/ajpheart.1997.272.6.h2869

  • Functional consequences of acute collagen degradation studied in crystalloid perfused rat hearts

    K. Todaka, T. Jiang, J. T. Chapman, A. Gu, S. M. Zhu, E. Herzog, J. S. Hochman, S. F. Steinberg, D. Burkhoff

    Basic Research in Cardiology   92 ( 3 )   147 - 158   1997.6

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    Objectives: The impact of acute collagen disruption by the disulfide donor, 5,5'-dithio-2-nitrobenzoic acid (DTNB) on ventricular properties was tested in rat hearts. Methods: Collagen was degraded acutely in 13 isolated, isovolumically contracting rat hearts by perfusion with 1 mM DTNB added to Krebs Henseleit solution for 1 hour followed by 2-hour perfusion with normal solution. Another 13 hearts were perfused with normal solution for 3 hours (Control). Results: Collagen content was 3.5 ± 0.5% of ventricular dry weight in control group compared with 2.1 ± 0.4% in DTNB group (decrease by 40%, p < 0.01). Scanning electron micrographs revealed loss of the delicate collagen network surrounding muscle fibers in DTNB treated hearts. Developed pressure at a fixed volume decreased to 86 ± 17% of the baseline value after 3-hour perfusion in the control group, whereas in DTNB treated hearts developed pressure fell to 68 ± 13% (p < 0.01). End-diastolic pressure was set at 5 mmHg at the beginning of the experiment and rose to 15 ± 8 mmHg in control and 30 ± 13 mmHg (p < 0.01) in the treated hearts. Concomitantly, wet-to-dry weight ratio increased from 5.63 ± 0.26 in control to 6.07 ± 0.11 (p < 0.05) in the DTNB treated hearts. A separate set of experiments on isolated myocytes excluded the possibility of a direct effect of DTNB on myocyte contractile function. Conclusions: These data suggested that with 40% collagen disruption by DTNB there is a significant increase in tissue edema that results in a decrease in chamber capacitance; in addition, there is a significant decrease in systolic performance which reflects the combined effect of edema and loss of collagen.

    DOI: 10.1007/BF00788632

  • Impact of exercise training on ventricular properties in a canine model of congestive heart failure

    Koji Todaka, J. I.E. Wang, Mathias Knecht, Richard Stennett, Milton Packer, Daniel Burkhoff

    American Journal of Physiology - Heart and Circulatory Physiology   41 ( 3 )   1997.3

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    Exercise training improves functional class in patients with chronic heart failure (CHF) via effects on the periphery with no previously documented effect on intrinsic left ventricular (LV) properties. However, because methods used to evaluate in vivo LV function are limited, it is possible that some effects of exercise training on the failing heart have thus far eluded detection. Twelve dogs were instrumented for cardiac pacing and hemodynamic recordings. Hearts were paced rapidly for 4 wk. Six of the dogs received daily treadmill exercise (CHFEX, 4.4 km/h, 2 h/day) concurrent with rapid pacing, while the other dogs remained sedentary (CHFs). Hemodynamic measurements taken in vivo at the end of 4 wk revealed relative preservation of maximum rate of pressure rise (2, 540 ±440 vs. 1, 720 ±300 mmHg/s, P < 0.05) and LV end-diastolic pressure (9 ±5 vs. 19 ±4 mmHg, P < 0.05) in CHFEX compared with CHFs. The hearts were then isolated and cross perfused for in vitro measurement of isovolumic pressure-volume relations; these results were compared with those of six normal dogs (N). Systolic function was similarly depressed in both groups of pacing animals [end-systolic elastance (Ees) values of 1.66 ±0.47 in CHFS, 1.77 ±0.38 in CHFEX, and 3.05 ±0.81 mmHg/ml in N, with no changes in volume axis interceptors of the end-systolic pressure-volume relationship]. The diastolic myocardial stiffness constant, k, was elevated in CHFs and was normalized by exercise training (32 ±3 in CHFs, 21 ±3 in CHFEx, 20 ±4 in N). Thus daily exercise training preserved in vivo hemodynamics during 4 wk of rapid cardiac pacing and was accompanied by a significant change in diastolic myocardial stiffness in vitro. These findings suggest that changes in heart function may contribute to the overall beneficial hemodynamic effects of exercise training in CHF by a significant effect on diastolic properties. Copyright © 1997 the American Physiological Society.

  • Characterizing ventricular mechanics and energetics following repeated coronary microembolization

    Koji Todaka, David Leibowitz, Shunichi Homma, Peter E. Fisher, Carolyn Derosa, Richard Stennett, Milton Packer, Daniel Burkhoff

    American Journal of Physiology - Heart and Circulatory Physiology   272 ( 1 41-1 )   1997.1

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    Myocardial mechanics and energetics were investigated in an animal model of moderate chronic heart failure (CHF) created by repeated coronary microembolizations in six dogs. The final fractional area change was 34 ± 4%. Hearts of these animals were isolated and cross-perfused, and balloons were placed in the left ventricle (LV). Chamber contractile state was markedly depressed in embolized hearts as assessed by the slope (E(es): 2.74 ± 0.49 vs. 4.00 ± 1.18 mmHg/ml, P < 0.01) and volume axis intercept (V0: 8.7 ± 5.9 vs. 1.0 ± 3.2 ml, P < 0.01) of end-systolic pressure-volume relation compared with a group of six normal dogs. The end-diastolic pressure-volume relation of embolized hearts was shifted to the right, indicating a dilation of the LV. However, systolic and diastolic stress- strain relationships were similar in the two groups, suggesting that the average myocardial properties of the embolized hearts are similar to those of normal hearts. The relationship between oxygen consumption and pressure- volume area in embolized hearts had smaller intercept (2.98 ± 0.44 vs. 3.92 ± 0.39 x 10-2 ml O2 · beat-1 · 100 g LV-1 P < 0.01) compared with the control group, with no change in the slope. These results contrast with previous findings in pacing CHF and serve as an important characterization of ventricular properties in this model of CHF from different etiology.

    DOI: 10.1152/ajpheart.1997.272.1.h186

  • Effects of levosimendan on myocardial contractility and oxygen consumption. Reviewed International journal

    Todaka K, Wang J, Yi GH, Stennett R, Knecht M, Packer M, Burkhoff D

    Journal of Pharmacology & Experimental Therapeutics   1996.10

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  • Effects of levosimendan on myocardial contractility and oxygen consumption

    Koji Todaka, Jie Wang, Geng Hua Yi, Richard Stennett, Mathias Knecht, Milton Packer, Daniel Burkhoff

    Journal of Pharmacology and Experimental Therapeutics   279 ( 1 )   120 - 127   1996.10

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    Levosimendan is hypothesized to be primarily a calcium sensitizer in vitro. Therefore, its inotropic action may be similar in both the normal and the congestive heart failure (CHF) state, and it may be associated with a decreased energetic cost of inotropism in vivo. To test these hypotheses, we gave levosimendan to cross-circulated isolated hearts from normal (n = 11) and CHF (n = 7, 4-week rapid pacing) dogs. Peak isovolumic left ventricular pressure at an end-diastolic pressure of 5 mm Hg (P(max,5)) measured by an intraventricular balloon was 120 ± 15 mm Hg in normal dogs, and it was increased by ~40% in response to ~0.63 μM levosimendan. In CHF dogs, base- line P(max,5)) was only 60 ± 12 mm Hg (P < .01 compared to normals), and ~8.4 μM levosimendan (P < .05) was required to increase P(max,5)) by ~40%. The inotropic actions were associated with increases in unloaded myocardial oxygen consumption by comparable amounts in normal and failing hearts. The blunted inotropic response in CHF and the energetic cost of inotropism were also comparable to those obtained with isoproterenol. In other studies, there was no significant inotropic action of levosimendan in Langendorff-perfused rat hearts (n = 5), and intracellular calcium concentration, estimated by macroinjected aequorin, in ferret hearts (n = 2) increased dose-dependently. These findings suggest that inotropic actions of levosimendan in vivo may be mediated in part by factors other than calcium sensitization.

  • Optimal coupling of the left ventricle with the arterial system

    K. Sunagawa, M. Sugimachi, K. Todaka, T. Kobota, K. Hayashida, R. Itaya, A. Chishaki, A. Takeshita

    Basic Research in Cardiology   88 ( SUPPL. 2 )   75 - 90   1993.6

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    In the human the heart contracts more than 2.0 billion times during the lifetime. The total amount of energy required in this period is equivalent to lift a huge tanker (more than 200 thousand tons) above your head. Thus there is no question that the heart requires a huge amount of energy. Since minimization of energy requirements would be one of the major design goals of the cardiovascular system, we investigated energy efficiency of ventriculo-arterial coupling under various conditions. In normal conscious dogs, the arterial system extracted maximal work from the left ventricle during exercise as well as at rest. At the same time,the energy consumption of the left ventricle to support the peripheral demand was minimum. This optimal coupling condition was well maintained despite changes in blood volume. The baroreflex system appeared to play a crucial role in this optimization. In the presence of left ventricular dysfunction, however, this optimality was no longer maintained. We conclude that the efficiency of cardiac contraction is fairly well maintained under various stresses as long as left ventricular function is normal.

  • Dynamic effects of carotid sinus baroreflex on ventriculoarterial coupling studied in anesthetized dogs

    T. Kubota, J. Alexander, R. Itaya, K. Todaka, M. Sugimachi, K. Sunagawa, Y. Nose, A. Takeshita

    Circulation Research   70 ( 5 )   1044 - 1053   1992.5

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    We evaluated dynamic effects of the carotid sinus baroreflex on ventriculoarterial coupling. In seven anesthetized, vagotomized dogs, we bilaterally isolated carotid sinuses and randomly changed carotid sinus pressure while measuring aortic pressure, aortic flow, and left ventricular pressure. Estimating left ventricular end-systolic elastance (E(es)) and effective arterial elastance (E(a)) on a beat-to-beat basis, we determined transfer functions from the carotid sinus pressure to E(es) (H(Ees)) and from the carotid sinus pressure to E(a) (H(Ea)) over the frequency range spanning 0.002-0.25 Hz. Both H(Ees) and H(Ea) exhibited characteristics of a second- order low-pass filter. The gains of H(Ees) and H(Ea) were 0.085±0.065 (mean±SD) and 0.081±0.049 mm Hg/ml/mm Hg, respectively. There were no significant differences in natural frequencies (0.039±0.013 versus 0.039±0.007 Hz) or damping ratios (0.65±0.11 versus 0.64±0.24). The results indicated that the carotid sinus baroreflex dynamically altered E(es) and E(a) to the same extent in the process of stabilizing arterial pressure. Because the arterial system extracts maximal external work from a given heart when E(a) equals E(es), the carotid sinus baroreflex appeared to be designed to regulate the ventricular and arterial properties to optimize the energy transmission from the left ventricle to the arterial system in anesthetized, vagotomized dogs.

    DOI: 10.1161/01.RES.70.5.1044

  • Effects of the new cardiotonic phosphodiesterase inhibitor 1,2-dihydro-5-imidazo[1,2-a]pyridin-6-yl-6-methyl-2-oxo-3-pyridine-car bonitrile hydrochloride monohydrate on aortic input impedance

    T. Kubota, R. Itaya, K. Todaka, M. Sugimachi, K. Sunagawa, A. Takeshita

    Arzneimittel-Forschung/Drug Research   41 ( 12 )   1211 - 1215   1991.12

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    Beneficial effects of cardiotonic phosphodiesterase inhibitors on congestive heart failure are possibly mediated in part by a reduction of afterload. 1,2-Dihydro-5-imidazo[1,2-a]pyridin-6-yl-6-methyl-2-oxo-3-pyridine-car bonitrile hydrochloride monohydrate (E-1020, CAS 119615-63-3), a new cardiotonic phosphodiesterase inhibitor was evaluated for its effect on aortic input impedance in eight anesthetized open-chest dogs. First instantaneous aortic pressure and flow under random ventricular pacing before and after E-1020 infusions (10, 30, and 100 μg/kg i.v.) were measured. Then aortic input impedance over the frequency range of 0.024 to 20 Hz was estimated using a multichannel autoregressive model. With the infusion of E-1020, aortic input impedance was decreased in the low frequency range (below 0.1 Hz) and shifted leftward in the transitional frequency range (from 0.1 to 2 Hz), while it remained unchanged in the high frequency range (above 2 Hz). Parameterization of the aortic input impedance using a three-element Windkessel model indicated that E-1020 (at a dose of 100 μg/kg i.v.) decreased arterial resistance by 35% (p < 0. 01) and increased arterial compliance by 12% (p < 0. 01). It is concluded that E-1020 improves cardiac performance by unloading static and dynamic afterload in addition to its cardiotonic effect.

  • Autoregressive analysis of aortic input impedance: Comparison with Fourier transform

    T. Kubota, R. Itaya, J. Alexander, K. Todaka, M. Sugimachi, K. Sunagawa

    American Journal of Physiology - Heart and Circulatory Physiology   260 ( 3 29-3 )   1991.3

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    We evaluated the advantages of the autoregressive (AR) model over the conventional Fourier transform in estimating aortic input impedance. In 10 anesthetized open-chest dogs, we digitized aortic pressure and flow at 200 Hz for 51.20 s under random ventricular pacing and subdivided them into five segments. We obtained aortic input impedance over the frequency range of 0.1-20 Hz both by AR model and by Fourier transform for various lengths of data, i.e., from one to four consecutive segments. For any given data length, the impedance spectrum estimated by the AR model was smoother than that obtained by the Fourier transform. To evaluate the accuracy of the estimated impedance, we predicted instantaneous aortic pressure of the fifth segment by convolving corresponding aortic flow with the impulse response of aortic input impedance. The prediction error was less with the AR model than that resulting from Fourier transform as long as the number of the segments was less than four. We conclude that the AR model provides a more accurate estimate of aortic input impedance than does the Fourier transform when data length is limited.

    DOI: 10.1152/ajpheart.1991.260.3.h998

  • A new method to identify dynamic transduction properties of aortic baroreceptors

    M. Sugimachi, T. Imaizumi, K. Sunagawa, Y. Hirooka, K. Todaka, A. Takeshita, M. Nakamura

    American Journal of Physiology - Heart and Circulatory Physiology   258 ( 3 27-3 )   1990.3

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    Language:Others   Publishing type:Research paper (scientific journal)  

    We identified, in 17 α-chloralose-anesthetized rabbits, the dynamic transduction characteristics of the aortic arch baroreceptors using a 'white-noise technique'. We recorded aortic pressure and aortic depressor nerve activity while perturbing pressure by rapid, intermittent ventricular pacing (400 beats/min). Dividing the cross-power spectrum between nerve activity and pressure by the power spectrum of pressure yielded the transfer function. The gain of the transfer function increased threefold as the frequency increased from 0.005 to 5 Hz, suggesting that the baroreceptors responded primarily to dynamic rather than to static changes in pressure. To quantify the nonlinear properties of baroreceptor transduction, we compared measured instantaneous nerve activity with that linearly predicted. We demonstrated that the major nonlinearity was attributable to 'threshold'. The overall baroreceptor transduction properties could be represented by a cascade connection of a linear subsystem followed by a nonlinear subsystem with threshold. The white-noise technique made it possible to identify the unbiased linear properties in a nonlinear system, and thus was very useful in identifying complex biological systems.

    DOI: 10.1152/ajpheart.1990.258.3.h887

  • Optimal afterload for the heart vs. optimal heart for the afterload.

    M. Sugimachi, K. Todaka, K. Sunagawa, M. Nakamura

    Frontiers of medical and biological engineering : the international journal of the Japan Society of Medical Electronics and Biological Engineering   2 ( 3 )   217 - 221   1990.3

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    Language:Others   Publishing type:Research paper (scientific journal)  

  • Random exercise stress test in diagnosing effort angina

    A. Suyama, K. Sunagawa, K. Hayashida, M. Sugimachi, K. Todaka, Y. Nose, M. Nakamura

    Circulation   78 ( 4 I )   825 - 830   1988.10

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    Language:Others   Publishing type:Research paper (scientific journal)  

    To improve the performance of exercise stress testing in the diagnosis of effort angina while minimizing risks of serious complications, we evaluated an impulse response of ST changes, which is a transient ST response resulting from a hypothetical, strenous-impulselike exercise, without actually imposing the strenuous load. To obtain the impulse response, subjects walked intermittently according to a computer-generated random binary sequence on a treadmill for 20 minutes (with a constant speed of 1.7 mph and a slope of 10&#37;). We used Fourier transform for beat-to-beat changes in ST level and the binary sequence of exercise. We then determined the transfer function by taking the ratio of Fourier transformed ST level to exercise over the frequency range of 0.5 through 5.0 cycles/min. Converting the transfer function to the time domain yielded the impulse response of ST change. The subjects consisted of 49 patients (60 ± 9 years) with effort angina, 13 patients with atypical chest pain (56 ± 9 years), and 30 healthy, male volunteers (23 ± 7 years). In 82 subjects (89&#37;), the ST impulse response showed an initial depression followed by a smooth, gradual restoration toward the preexercise ST level (type I response). The average duration of the initial depression was 8 ± 3 seconds in the healthy volunteers, whereas it was significantly prolonged to 23 ± 14 seconds in effort angina (p < 0.05). The depression in patients with atypical chest pain was not significantly different from that in the healthy volunteers. Although the level of exercise was milder in the proposed exercise test than in the conventional treadmill exercise test, the sensitivity and the specificity were significantly better in the proposed exercise test than in the conventional one in the same population. We conclude that this random exercise test is a sensitive, safe tool and is very accurate for the diagnosis of effort angina.

    DOI: 10.1161/01.CIR.78.4.825

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Books

  • 徹底ガイド 心不全Q&A ―プレホスピタルから 慢性期まで―(第2版)

    戸高 浩司, 佐藤 直樹(Role:Joint author)

    総合医学社  2013.10 

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    Responsible for pages:急性期後入院中に,どのように経口薬を導入していくのか   Language:Japanese   Book type:Scholarly book

  • 日本人急性冠症候群における冠動脈形成術前スタチン投与の有効性に関する臨床疫学研究

    戸高, 浩司

    [九州大学]  2008.3 

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    Responsible for pages:総ページ数:15枚   Language:Japanese  

Presentations

  • 分散型臨床試験のシステム・運用両面からの 構築:臨床研究中核病院における DCT 整備の ための取組み

    戸高 浩司1)、小早川 優子1)、船越 公太1)、森山 智彦3)、森田 憲司1)、髙栁 直美1)、坂梨 健二1)、河 原 直人1)、山下 貴範2)、中島 直樹2)、中熊 英貴6)、松木 絵里5)、鍬塚 八千代7)、安藤 昌彦7)、山中雅代8)、小澤 秀志9)、河野 健一10)、堀松 高博10)、丹 浩伸11)、櫻井 淳11)

    第15回臨床試験学会  2024.3 

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    Event date: 2024.3

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:大阪   Country:Japan  

    【背景・目的】
    日本における医師主導治験は、採算性の問題から企業が積極的に開発しない医療技術を評価することに用いられているが、競争的研究費の減少AROリソースの問題を解決する手段の一つとして、分散型臨床試験のシステム・運用両面からの構築を、臨床研究中核病院が連携して進めている。
    【方法】
    令和4年度はAMED医療技術実用化総合促進事業先進的臨床研究基盤整備プログラム、令和5年度は医療技術実用化総合促進事業DCTの取組みにて整備を進めた。令和4年度は5つのワーキンググループ、令和5年度はさらに2つのワーキンググループを追加設置した。DCTの整備とは別に治験効率化のシステムの核として標準化電子クリニカルパスを基盤とする電子ワークシートの作り込みと、模擬治験のシミュレーションを通じて周辺の体制整備を行なった。
    【結果】
    11施設3ベンダーの電子カルテ内に標準化電子ワークシートを構築し、全ての臨床研究中核病院にて模擬治験を実施した。令和5年にはICH-M11ステップ3(PMDA)、eConsentガイドライン(厚労省)、DCTドラフトガイダンス(FDA)、医療情報システムの安全管理に関するガイドライン第6.0版(厚労省)等規制上の変化があり、これらにも対応した。
    【考察】
    臨床研究中核病院が連携して分散型臨床試験の整備に取り組み、プロトコルの記載方法、多くのITシステムを使い分ける煩雑さ、多くの関係部署との調整にかかる時間的コスト、訪問看護ステーションの契約、治験薬配送のコスト高等、多くの課題を抽出することができた。今後も継続して取り組む必要がある。

  • DX in Clinical Trial Invited International conference

    戸高浩司

    The 4th NCGM/CCS/DIT International Symposium on Clinical Research/Trials  2024.2 

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    Event date: 2024.2

    Language:English   Presentation type:Oral presentation (general)  

    Venue:東京都新宿NCGM   Country:Japan  

    Dx in clinical trials
    In the world of clinical trials, efficiency improvements through digitalization and further Dx, digital transformation are being called for, and implementation is progressing. There are many elements in clinical trials, such as subject collection, trial quality control, and data collection, where digitalization can be effective, such as web advertisements, logical checks, and electronic source materials (eSource). Furthermore, in recent years, decentralized clinical trials (DCT), in which subjects do not visit hospital facilities, have been explored for efficiency and patient-centered medical care. Due to the coronavirus pandemic, attention has been paid to the fact that it can be carried out at patients' home, and developed countries seem to have made rapid progress in developing it. However, dealing with pharmaceutical regulations is complicated, and many face-to-face tasks are being replaced with remote operations using digitalization and IT while each step is compliant with GCP. For example, there are many issues that need to be solved on a different level than the digital technology that makes remote medical treatment possible, such as who will ensure the safety of administering investigational drugs in remote locations other than clinical trial facilities.
    In this article, I would like to introduce the implementation status of clinical trial Dx in Japan and its challenges, and discuss how it can be applied to LMIC.

  • DX in Clinical Trial Invited International conference

    戸高浩司

    The 4th NCGM/CCS/DIT International Symposium on Clinical Research/Trials  2024.2 

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    Event date: 2024.2

    Language:English   Presentation type:Oral presentation (general)  

    Venue:東京都新宿NCGM   Country:Japan  

  • The importance of Academic Research Organizations in recent medical product Research and Development Invited International conference

    戸高浩司

    Kyushu University Forum “Kyudai Now” in Kuala Lumpur, Malaysia  2024.1 

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    Event date: 2024.1

    Language:English   Presentation type:Oral presentation (general)  

    Venue:Kuala Lumpur, Malaysia   Country:Malaysia  

  • 医師主導治験の具体的事例から見るAROの役割

    戸高浩司

    第44回日本臨床薬理学会学術総会 第97回日本薬理学会年会  2023.12 

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    Event date: 2023.12

    Language:Japanese   Presentation type:Symposium, workshop panel (public)  

    Venue:神戸国際会議場・神戸国際展示場   Country:Japan  

  • 臨床研究中核病院におけるDCT推進の取り組み

    戸高浩司

    第44回日本臨床薬理学会学術総会 第97回日本薬理学会年会  2023.12 

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    Event date: 2023.12

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:神戸国際会議場・神戸国際展示場   Country:Japan  

  • 緊急対応における臨床試験のオペレーション向上

    戸高浩司

    第44回日本臨床薬理学会学術総会 第97回日本薬理学会年会  2023.12 

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    Event date: 2023.12

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:神戸国際会議場・神戸国際展示場   Country:Japan  

  • The importance of Academic Research Organizations in recent medical product Research and Development Invited International conference

    戸高浩司

    BICON-2023, Biyani International Conference on Nurturing Academic Entrepreneurs with Industrial Partnerships  2023.11 

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    Event date: 2023.11

    Language:English   Presentation type:Oral presentation (general)  

    Venue:Jaipur, India   Country:India  

    In 2007, the Japanese government began establishing academic research organizations (AROs) at several universities in order to overcome the situation in Japan, where promising basic research results had not led to the practical application of new drugs. At the same time, an R&D method in which AROs incubate inventions from academia to some extent and then license them out to pharmaceutical companies is becoming a global trend. The majority of new drugs approved by the US FDA from 1998 to 2007 were discoveries made in academia. In Japan as well, results are beginning to emerge, with 23 cases being approved over the three-year period from 2020 to 2022 through a system of investigator- initiated clinical trials for approval purpose, which is rare in the world. From the beginning, Kyushu University received support from the Ministry of Education and the Ministry of Health through the Translational Research Hub Project and Clinical Research Core Hospital Project, respectively, and has been developing an ARO staffed by around 100 experts. We have a system in place to cover every step to mature basic research into new drugs (intellectual property, pharmaceutical affairs, toxicology, engineering, CMC [chemistry, manufacturing and control], project management, data management, biostatistics, trial quality control, IT, ethics, regulatory science) within the university. Although there are many development targets for incurable and rare diseases that are difficult for pharmaceutical and medical device companies to reach and also to make a profit, the morale of the staff is high in delivering new treatments to bedside, which leads to gathering talented people and efficient development. Examples of approved products include alveolar bone fillers and staining materials for eye surgery, which have become de facto standard products and are used around the world. We also have new drug development technologies that have a wide range of applications, including the production of protein preparations by introducing genes into special silkworms that have been cultivated in the Faculty of Agriculture for over 100 years, and technology that allows even larger molecules of 500 Da or more to penetrate into the body through normal skin.
    We are actively working on international contributions, and especially in Asia. We are conducting joint research and development with local academia to resolve unmet medical needs such as infectious diseases, which are caused by regionally specific circumstances. Your country's CDSCO have a reference country rule that simplifies domestic evaluations by referring to approvals in Japan, which can hopefully be utilized. We hope that the introduction of our university's activities in this lecture will lead to joint development and international clinical trials with academia in your country.

  • The importance of Academic Research Organizations in recent medical product Research and Development Invited International conference

    戸高浩司

    BICON-2023, Biyani International Conference on Nurturing Academic Entrepreneurs with Industrial Partnerships  2023.11 

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    Event date: 2023.11

    Language:English   Presentation type:Oral presentation (general)  

    Venue:Jaipur, India   Country:India  

  • 九州大学における「総合知」融合研究のライフサイエンスへの展開

    池元英樹 戸高浩司

    ra協議会2023 (8/8-9/2023 東京都八王子市多摩メッセ)  2023.8 

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    Event date: 2023.8

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:東京都八王子市多摩メッセ   Country:Japan  

  • 先進的臨床研究環境基盤整備の一環としてのDCT実施体制構築 Invited

    戸高浩司

    RS学会 WEBシンポジウム~治験・臨床試験を巡る動き~  2023.5 

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    Event date: 2023.5

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:東京都新橋   Country:Japan  

  • 倫理教育講演

    戸高浩司

    第88回日本温泉気候物理医学会総会・学術集会  2023.5 

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    Event date: 2023.5

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:別府国際コンベンションセンター   Country:Japan  

  • 分散型臨床試験DCTとデジタルヘルス

    戸高浩司

    糖尿病学会  2023.5 

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    Event date: 2023.5

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:鹿児島市城山ホテル   Country:Japan  

  • 創薬とレギュラトリー・サイエンス (ランチョン)

    戸高浩司

    第95回日本薬理学会年会 (R4年3月9日、福岡hybrid)  2022.3 

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    Event date: 2022.3

    Language:Japanese  

    Country:Japan  

  • AROを具体的事例より考える: 科学的なエビデンスの確立と AROの多様性 AROを含む医療機関の調査と活用 Invited

    戸高浩司

    第42回日本臨床薬理学会学術総会  2021.12 

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    Event date: 2021.12

    Language:Japanese   Presentation type:Symposium, workshop panel (public)  

    Country:Japan  

  • ローカルネットワークを活用した拠点のあり方と今後のシーズ開発の方向性 アカデミアネットワークの虚実 Invited

    戸高浩司

    ARO協議会第8回学術集会(岡山web)  2021.9 

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    Event date: 2021.9

    Language:Japanese  

    Country:Japan  

  • ニーズ・プル開発とテクノロジー・プッシュ、規制の狭間で Invited

    戸高浩司

    第1回 日本バイオデザイン学会定期学術集会  2021.3 

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    Event date: 2021.3

    Language:Japanese   Presentation type:Symposium, workshop panel (public)  

    Venue:大阪   Country:Japan  

  • COVID-19により導入が加速したR-SDVへの当院の取り組み

    戸高浩司, 木島 真一, 坂井 悟, 坂梨 健二, 船越 公太, 小松高幸, 吉崎真司, 高田敦史, 山下貴範, 中島直樹, 馬場 英司

    日本臨床試験学会第12回学術集会総会  2021.2 

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    Event date: 2021.2

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:東京   Country:Japan  

  • 我が国のAROの多様性について~ARO機能推進事業~ Invited

    戸高浩司

    第41回日本臨床薬理学会学術総会  2020.12 

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    Event date: 2020.12

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:福岡   Country:Japan  

  • 九州大学病院での特定臨床研究における疾病等報告の実態と運用の課題

    戸高 浩司、木村 真紀, 武冨 律子, 城 円, 原 春香, 原田 公子, 河原 直人, 馬場 英司

    日本臨床試験学会第11回学術集会総会  2020.2 

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    Event date: 2020.2

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:東京   Country:Japan  

  • PLS回帰による本邦AROのリソースと成果の関連分析

    戸高浩司、城 円、岸本淳司

    日本臨床試験学会第11回学術集会総会  2020.2 

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    Event date: 2020.2

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:東京   Country:Japan  

  • ポジショニング分析を用いた本邦AROの類型化

    戸高浩司、遠山岳詩、船越公太、岸本淳司

    第40回日本臨床薬理学会学術総会  2019.12 

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    Event date: 2019.12

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:東京   Country:Japan  

  • AROの現況と将来 ~AMED ARO機能評価事業~ Invited

    戸高 浩司

    AMED革新的医療技術創出拠点プロジェクト平成30年度成果報告会  2019.2 

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    Event date: 2019.2

    Language:Japanese   Presentation type:Symposium, workshop panel (public)  

    Venue:東京   Country:Japan  

  • 11[beta]-HSD type 1 inhibitor ameliorates metabolic disorders associated with hypercortisolemia: A clinical trial to assess its safety and efficacy in Japanese patients with refractory Cushing's syndrome and subclinical Cushing's syndrome. International conference

    Oda S, Nagata H, Ashida K, Sakamoto S, Uchiyama M, Nagayama A, Iwata S, Todaka K, Nakanishi Y, Nomura M

    Society for Endocrinology BES  2018.11 

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    Event date: 2018.11

    Language:English   Presentation type:Oral presentation (general)  

    Venue:Glasgow   Country:United Kingdom  

  • 血圧計の進化と血圧診療の深化 Invited

    戸高 浩司

    ARO協議会第6回学術集会  2018.8 

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    Event date: 2018.8 - 2018.9

    Language:Japanese   Presentation type:Symposium, workshop panel (public)  

    Venue:福岡   Country:Japan  

  • Investigator initiated clinical trial of cancer vaccine OCV-C01 in advanced and recurrent biliary tract cancer. International conference

    Murahashi M, Ogata H, Okazaki T, Hijikata Y, Yamada K, Tsuruta T, Kishimoto J, Funakoshi K, Todaka K, Nakanishi Y, Tani K.

    The Japanese Society of Medical Oncology Annual Meeting  2018.7 

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    Event date: 2018.7

    Language:English   Presentation type:Oral presentation (general)  

    Venue:Kobe   Country:Japan  

  • Unmet Needs: 日本と米国、欧州の違いを踏まえて「新しい医療機器の導入が遅いと感じる理由」 Invited

    戸高 浩司

    ストラクチャークラブ・ジャパン ライブデモンストレーション2017  2017.11 

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    Event date: 2017.11

    Language:Japanese   Presentation type:Symposium, workshop panel (public)  

    Venue:福岡   Country:Japan  

  • 臨床研究と医薬品等開発のポイント Invited

    戸高 浩司

    日本小児麻酔学会第23回大会  2017.10 

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    Event date: 2017.10

    Language:Japanese   Presentation type:Oral presentation (invited, special)  

    Venue:福岡   Country:Japan  

  • 西の拠点としてのシーズ発掘・育成ネットワーク Invited

    戸高 浩司、杉山 大介、中西 洋一

    ARO協議会第5回学術集会  2017.9 

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    Event date: 2017.9

    Language:Japanese   Presentation type:Symposium, workshop panel (public)  

    Venue:名古屋   Country:Japan  

  • 医療機器開発戦略とARO Invited

    戸高 浩司

    第6回 医師主導による医療機器開発のためのニーズ創出・事業化支援セミナー  2017.2 

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    Event date: 2017.2

    Language:Japanese   Presentation type:Symposium, workshop panel (public)  

    Venue:福岡   Country:Japan  

  • 九州大学AROと医療機器開発 Invited

    戸高 浩司

    第316回 RISTフォーラム  2017.1 

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    Event date: 2017.1

    Language:Japanese   Presentation type:Oral presentation (invited, special)  

    Venue:熊本   Country:Japan  

  • 医師主導治験~その意義とPIの責務~、安全性管理 Invited

    戸高 浩司

    AMED臨床研究・治験従事者研修  2017.1 

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    Event date: 2017.1

    Language:Japanese   Presentation type:Public lecture, seminar, tutorial, course, or other speech  

    Venue:福岡   Country:Japan  

  • Academic Research Organizationの役割ーデバイス実用化の観点からー Invited

    戸高 浩司

    ストラクチャークラブ・ジャパン ライブデモンストレーション2016  2016.10 

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    Event date: 2016.10

    Language:Japanese   Presentation type:Symposium, workshop panel (public)  

    Venue:京都   Country:Japan  

  • Academic Research Organization to promote medical device development at the university Invited International conference

    戸高 浩司

    2016 Japan Korea Joint Forum  2016.4 

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    Event date: 2016.4

    Language:English   Presentation type:Oral presentation (general)  

    Venue:Seoul   Country:Korea, Republic of  

  • 臨床研究と開発:Academic Research Organizationの役割 Invited

    戸高 浩司

    第77回日本臨床外科学会  2015.11 

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    Event date: 2015.11

    Language:Japanese   Presentation type:Public lecture, seminar, tutorial, course, or other speech  

    Venue:福岡市   Country:Japan  

  • 医療機器不具合自主報告の深層学習による自動分類

    船越 公太, 戸高 浩司, 砂川 賢二

    第35回医療情報学連合大会  2015.11 

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    Event date: 2015.11

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:沖縄   Country:Japan  

  • 医療機器開発に関する話題 Invited

    戸高 浩司

    第5回JSCTR-KRP Joint臨床研究セミナー  2015.9 

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    Event date: 2015.9

    Language:Japanese   Presentation type:Public lecture, seminar, tutorial, course, or other speech  

    Venue:福岡市   Country:Japan  

  • アカデミアが主導する革新的医薬品・医療機器開発の意義 Invited

    戸高 浩司

    第9回制御拠点協議会  2015.9 

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    Event date: 2015.9

    Language:Japanese   Presentation type:Public lecture, seminar, tutorial, course, or other speech  

    Venue:福岡市   Country:Japan  

  • 比例報告比による医療機器市販後シグナル検出

    船越 公太, 戸高 浩司, 砂川 賢二

    第5回 レギュラトリーサイエンス学会学術総会  2015.9 

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    Event date: 2015.9

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:東京   Country:Japan  

  • アカデミアが主導する革新的医薬品・医療機器開発の意義 AROの役割と意義

    戸高 浩司

    日本薬学会 第135回年会  2015.3 

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    Event date: 2015.3

    Language:Japanese   Presentation type:Symposium, workshop panel (public)  

    Venue:神戸市   Country:Japan  

  • 頸髄損傷患者における急性期から慢性期にかけての起立性低血圧およびその随伴症状について

    篠田 雅子, 柿野 貴盛, 大賀 泰寛, 村山 佳範, 樗木 晶子, 戸高 浩司, 砂川 賢二

    第6回ニューロリハビリテーション学会学術集会  2015.2 

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    Event date: 2015.2

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:秋田   Country:Japan  

  • 医療機器不具合自主報告のベイジアンフィルタによる自動分類

    船越 公太, 戸高 浩司, 砂川 賢二

    第34回医療情報学連合大会  2014.11 

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    Event date: 2014.11

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:千葉   Country:Japan  

  • アカデミア主導で展開する医薬品・医療機器開発の最前線 Frontline of the Academia-Induced Development of Pharmaceuticals and Medical Devices 九州大学における取組みについて

    戸高 浩司

    日本薬学会 第134回年会  2014.3 

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    Event date: 2014.3

    Language:Japanese   Presentation type:Symposium, workshop panel (public)  

    Venue:熊本市   Country:Japan  

  • レギュラトリーサイエンスと安全性医療機器市販後安全性評価 Invited

    戸高 浩司

    第22回日本コンピュータ外科学会大会  2013.9 

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    Event date: 2013.9

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:東京   Country:Japan  

    特別シンポジウム『革新的医療機器の実用化促進にむけて』

  • リスク・マトリックスによる医療機器市販後安全性評価

    溝尾 嘉章, 戸高 浩司, 船越 公太, 砂川 賢二

    第3回 レギュラトリーサイエンス学会学術総会  2013.9 

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    Event date: 2013.9

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:東京   Country:Japan  

  • 医療機器安全性評価へのリスク・マトリックス応用

    船越 公太, 戸高 浩司, 砂川 賢二

    第4回 レギュラトリーサイエンス学会学術総会  2014.9 

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    Event date: 2013.9

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:東京   Country:Japan  

  • Role of Academia in Japan: Koji Todaka (Kyushu University) Clinical and Translational Research in Japanese Academia. Invited International conference

    戸高 浩司

    第22回日本心血管インターベンション治療学会学術集会  2013.7 

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    Event date: 2013.7

    Language:English   Presentation type:Oral presentation (general)  

    Venue:神戸市   Country:Japan  

    Town Hall Meeting: “Global Harmonization for Medical Device Innovation”

  • Update from Working Group 2 Invited International conference

    戸高 浩司, Kazuhiro Sase, Masayuki Kawahara

    HBD  2013.7 

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    Event date: 2013.7

    Language:English   Presentation type:Symposium, workshop panel (public)  

    Venue:tokyo   Country:Japan  

    Japan-US HBD East 2013 (July 9 – 10, 2013, Tokyo)
    Kazuhiro Sase, Takeshi Nakatani, Koji Todaka, Masayuki Kawahara
    Update from Working Group 2

  • 臨床研究に関する倫理について Invited

    戸高 浩司

    GCP Basic Training セミナー  2013.6 

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    Event date: 2013.6

    Language:Japanese   Presentation type:Public lecture, seminar, tutorial, course, or other speech  

    Venue:福岡市   Country:Japan  

  • リスク・ベネフィット認知が医療技術受容に与える影響の国際比較 ―コレスポンデンス分析による検討―

    戸高 浩司

    臨床薬理学会  2012.12 

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    Event date: 2012.11 - 2012.12

    Language:Japanese   Presentation type:Oral presentation (general)  

    Venue:沖縄県   Country:Japan  

    【目的】薬や医療機器に対するリスク・ベネフィット認知が国内外で異なる可能性が指摘されている。ドラッグ/デバイスラグの一因とも考えられるがデータとしては皆無であるため国内外での直接比較を試みた。
    【方法】一般市民を対象として言語以外は同一のアンケート票を用いて多肢選択方式のインターネット調査を日米英で同時に行った。医療を含む科学技術についての認識や医療機器承認、規制当局に係る質問・認識等についての回答を比較分析した。年代・性分布が均等になるように割り付け、約3千人から有効な回答を得た。10の一般事象(喫煙、飲酒、車、飛行機、原子力発電、遺伝子組み換え作物、医療X線、抗生物質、ワクチン、ペースメーカ)それぞれの有用性/危険性/受容するかについて5点尺度(とても役立つ/危険/必ず受け容れる、やや役立つ、どちらとも言えず、余り役立たない、全く役立たない)の回答、厚生労働省や医師を信頼するか、何らかの治療歴があるか等についてコレスポンデンス分析を行った。
    【結果・考察】医療技術関係(上記後半4項目)に対する有用性/危険性/受容度は同様のマッピング傾向を示し治療歴の有無の影響は小さかった。ペースメーカと飛行機の受容は同じ傾向を示した。米国人、英国人は近くに位置し有用性/危険性/受容度について、「とても有用で、危険が小さく、受容する」と言ったはっきりとした回答とクラスターし、日本人は「どちらでもない」といった中庸回答が多くなる傾向があり第一軸において大きく離れていた。厚生労働省や医師に対する信頼は回答の明瞭さと関連があり必ずしも好意的な判断とは関連しなかった。
    【結論】リスク・ベネフィット認知には日本と米英で差異があり厚労省や医師に対する信頼がリスク・ベネフィットひいては受容するか否かの判断を明瞭にさせていることがコレスポンデンス分析から示唆された。

  • リスク・ベネフィット認知と医療技術受容の国際比較

    戸高浩司1)、岸本淳司1)、池田正行2)、池田浩治3)、中野壮陛4)、山本晴子5) 1)九州大学病院ARO次世代医療センター、2)長崎大学医歯薬学総合研究科、3)東北大学病院、4)財)医療機器センター、5)国立循環器病研究センター

    レギュラトリーサイエンス学会  2012.9 

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    Event date: 2012.9

    Presentation type:Oral presentation (general)  

    Venue:東京   Country:Japan  

    【目的】医療技術に対して本邦では有用性よりリスクを重要視する傾向が指摘されている。リスク・ベネフィット認知の違いはデバイスラグの遠因として興味深いが実際のデータは皆無であるため国内外での直接比較を試みた。
    【方法】一般市民を対象として言語以外は同一のアンケート票を用いて多肢選択方式のインターネット調査を日米英で同時に行った。医療を含む科学技術についての認識や医療機器承認、規制当局に係る質問・認識等について回答を比較した。
    【結果】年代・性分布が均等になるように割り付け、約3千人から有効な回答を得た。何らかの治療中である割合(=患者)は日本23%、米国43%、英国36%とやや日本が少ない傾向であった。
    木下らの手法に倣って科学技術を含む10の一般事象(喫煙、飲酒、車、飛行機、原子力発電、遺伝子組換作物、医療X線、抗生物質、ワクチン、ペースメーカ)について5点尺度(とても役立つ・危険、やや役立つ、どちらとも言えず、余り役立たない、全く役立たない)で有用性、危険性、受容するかについて尋ねた。5点尺度に+2〜—2の点を与えてその加重平均を計算し国ごとに10事象の散布図を描いた。有用性xと受容度yとの関係を直線回帰すると日本はy = 0.73x + 0.15、
    R² 0.85、米国y = 0.77x + 0.40、R² 0.95、英国y = 0.79x + 0.38、R² 0.93といずれも相関が高く、傾きはほぼ同じで日本より英米の切片が大きい事から全体に英米の受容が良い事が示唆された。危険性と受容の関係は英米の切片が大きいのは共通であるがR² は日米英それぞれ0.68、0.79、0.76とやや低くどの地域でも有用性がより重視されていると思われた。
     医療技術関係の4項目(X線、抗生物質、ワクチン、ペースメーカ)は差が小さいものの英>日>米の順に有用・危険でないと感じる割合が多かった。しかし受け容れるかどうかは英>米>日の順となり全般的受容度の低さが日本について大きく影響した。受容度の順番は奇しくも新薬や新医療機器が導入される一般的順序と一致した。
    【考察】本邦において医療技術の受容に危険性の認知が有用性より影響が大きいとの結果は簡易解析では得られなかった。何か副作用が起こった場合に元々英米より受容が良くない本邦においては更に受容度が低下してしまい、リスクを過大視しているように見えているのかもしれない。規制当局への信頼に関する質問では日本と英米で大差がついていることも背景として重要と考えられる。

  • 本邦での循環器領域における研究者主導大規模臨床試験実施の障壁

    戸高浩司、山本晴子

    第28回日本臨床薬理学会年会  2007.11 

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    Venue:栃木県前橋市   Country:Japan  

  • 新薬の承認審査 − 医師の役割 Invited

    戸高浩司

    第65回日本循環器学会総会・学術集会  2003.3 

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    Presentation type:Symposium, workshop panel (public)  

    Venue:福岡市   Country:Japan  

  • 新薬の承認審査 − 医師の役割 Invited

    戸高浩司

    第26回日本医学会総会  2003.4 

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    Venue:福岡市   Country:Japan  

  • パナルジン時代に如何に安全にDESを使用するか Invited

    戸高浩司

    第14回倉敷PCIライブデモンストレーションコース  2005.2 

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    Presentation type:Symposium, workshop panel (public)  

    Venue:北九州市   Country:Japan  

  • Foreign Clinical Data of Antithrombotic Drugs Invited

    戸高浩司

    第69回日本循環器学会総会・学術集会  2005.3 

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    Venue:横浜  

  • 早期DES導入のために - 行政的視点からの問題点- Invited

    戸高浩司

    第22回小倉ライブデモンストレーション  2005.4 

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    Venue:北九州  

  • 日本の新薬開発は特殊なのか? Invited

    戸高浩司

    第26回日本臨床薬理学会年会  2005.12 

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    Venue:大分県別府市  

  • Do we need combination products? Invited International conference

    Koji Todaka

    DIA, drug information association  2006.4 

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    Presentation type:Symposium, workshop panel (public)  

    Venue:Tokyo   Country:Japan  

  • 機構との付き合い方教えます Invited

    戸高浩司

    PharmaBuisinessセミナー  2006.7 

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    Venue:東京  

  • 福岡都市圏における心不全治療の実情アンケート Invited

    戸高浩司

    第232回 福岡心臓疾患治療談話会  2006.9 

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    Venue:福岡市  

  • 早期DES導入のために - 行政的視点からの問題点- Invited

    戸高浩司

    第7回日本心血管カテーテル治療学会学術集会  2007.8 

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    Venue:名古屋市   Country:Japan  

  • 駆出率が保持、軽度低下、低下した心不全患者の長期転帰 JROADHF(Long-term Outcomes of Heart Failure Patients with Preserved, Mildly Reduced, and Reduced Ejection Fraction: JROADHF)

    Nagata Takuya, Ide Tomomi, Tohyama Takeshi, Kaku Hidetaka, Enzan Nobuyuki, Matsushima Shoji, Ikeda Masataka, Katsuki Shunsuke, Nakano Yasuhiro, Hashimoto Toru, Matoba Tetsuya, Todaka Koji, Tsutsui Hiroyuki

    日本循環器学会学術集会抄録集  2023.3  (一社)日本循環器学会

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  • 迷走神経刺激カテーテルは犬の急性心不全モデルにおいて心拍数と心筋酸素消費量を迅速に調節する(Vagal Nerve Stimulation Catheter Rapidly Modulates Heart Rate and Myocardial Oxygen Consumption in a Dog Model of Acute Heart Failure)

    此内 緑, 横田 翔平, 坂本 和生, 石田 英子, 遠山 岳詩, 松下 裕貴, 鵜木 崇, 横井 愛美, 戸高 浩司, 朔 啓太

    日本循環器学会学術集会抄録集  2023.3  (一社)日本循環器学会

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  • 糖尿病診療のデジタルヘルスの展開 分散型臨床試験DCTとデジタルヘルス

    戸高 浩司, 船越 公太, 中島 直樹, 山下 貴範

    糖尿病  2023.4  (一社)日本糖尿病学会

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  • 筋萎縮性側索硬化症における疾患進行速度の新しい定量的指標(A novel quantitative indicator for disease progression rate in amyotrophic lateral sclerosis)

    Kobayakawa Yuko, Todaka Koji, Hashimoto Yu, Ko Senri, Kishimoto Junji, Yamasaki Ryo, Isobe Noriko

    臨床神経学  2022.10  (一社)日本神経学会

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  • 疾患レジストリデータベースのコンピュータ化システムバリデーション対応

    宮原 冬佳, 川崎 史織, 山下 貴範, 平田 明恵, 池田 真一郎, 坂梨 健二, 船越 公太, 神田橋 忠, 戸高 浩司, 中島 直樹

    医療情報学連合大会論文集  2023.11  (一社)日本医療情報学会

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  • 治験に関わる薬剤師のトレーニングの現状とその評価

    長谷部 結衣, 西田 朋子, 高木 雅恵, 田中 智佳, 田中 紗里音, 三木 翔伍, 了戒 百合子, 田中 瑠美, 田島 壮一郎, 坂口 裕美, 戸高 浩司, 家入 一郎

    日本臨床薬理学会学術総会抄録集  2022.12  (一社)日本臨床薬理学会

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  • 治験におけるリモートSDVシステムの開発とその導入における取り組み

    田島 壮一郎, 中屋 純子, 坂梨 健二, 吉崎 真司, 高田 敦史, 武田 真樹, 船越 公太, 家入 一郎, 中島 直樹, 戸高 浩司

    日本臨床薬理学会学術総会抄録集  2024.1  (一社)日本臨床薬理学会

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  • 本邦における医師主導治験の役割について

    戸高 浩司

    日本臨床薬理学会学術総会抄録集  2022.12  (一社)日本臨床薬理学会

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  • 医師主導治験の具体的事例から見るAROの役割

    戸高 浩司

    日本臨床薬理学会学術総会抄録集  2024.1  (一社)日本臨床薬理学会

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  • 公正な研究活動(Fair Research Activities)

    Todaka Koji

    日本温泉気候物理医学会雑誌  2024.2  (一社)日本温泉気候物理医学会

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  • 九州大学病院における治験関連文書の電磁的管理システムに対するモニタリング担当者の評価

    三木 翔伍, 田島 壮一郎, 田中 瑠美, 高平 育子, 下條 晃, 武田 真樹, 家入 一郎, 戸高 浩司

    日本臨床薬理学会学術総会抄録集  2024.1  (一社)日本臨床薬理学会

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  • 上肢に運動機能障害を有する神経筋疾患患者における電子端末の利用状況調査 IT活用時の留意点を考える

    小早川 優子, 江 千里, 橋本 侑, 原田 幸子, 戸高 浩司, 山崎 亮, 磯部 紀子

    日本難病医療ネットワーク学会機関誌  2023.11  (一社)日本難病医療ネットワーク学会

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  • クリニカルパスの標準化とその効果

    若田 好史, 山下 貴範, 中熊 英貴, 的場 哲哉, 船越 公太, 戸高 浩司, 岡田 美保子, 中島 直樹, 副島 秀久

    日本医療情報学会春季学術大会プログラム・抄録集  2023.6  (一社)日本医療情報学会

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  • ePathの概要とその活用、効果について

    中熊 英貴, 小妻 幸男, 山下 貴範, 若田 好史, 的場 哲哉, 松木 絵里, 船越 公太, 戸高 浩司, 中島 直樹, 岡田 美保子, 副島 秀久

    日本医療情報学会春季学術大会プログラム・抄録集  2024.6  (一社)日本医療情報学会

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  • ePathの概要とその活用、効果について

    中熊 英貴, 小妻 幸男, 山下 貴範, 若田 好史, 的場 哲哉, 松木 絵里, 船越 公太, 戸高 浩司, 中島 直樹, 岡田 美保子, 副島 秀久

    医療情報学連合大会論文集  2023.11  (一社)日本医療情報学会

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  • DPCデータから心不全患者の1年死亡率を予測する機械学習ベースの予測モデル(Machine Learning-based Model for Predicting One-year Mortality of Heart Failure Patients from DPC Data)

    Tohyama Takeshi, Ide Tomomi, Ikeda Masataka, Enzan Nobuyuki, Matsushima Shoji, Funakoshi Kota, Todaka Koji, Tsutsui Hiroyuki

    日本循環器学会学術集会抄録集  2022.3  (一社)日本循環器学会

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  • DCTと臨床研究中核病院、eWorksheet

    戸高 浩司

    日本臨床薬理学会学術総会抄録集  2024.1  (一社)日本臨床薬理学会

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  • AIが変える循環器領域 ディープラーニングによる術後心房細動ハイリスク患者の検出(Deep Learning Approach to Detect the High-risk Patients of Postoperative Atrial Fibrillation)

    遠山 岳詩, Ide Tomomi, Ikeda Masataka, Nagata Takuya, Tagawa Koshiro, Hirose Masayuki, Funakoshi Kouta, Sakamoto Kazuo, Kishimoto Junji, Todaka Koji, Nakashima Naoki, Tsutsui Hiroyuki

    日本循環器学会学術集会抄録集  2023.3  (一社)日本循環器学会

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MISC

  • 九州大学における橋渡し研究、精密医療の開発について

    戸高 浩司

    precision medicine   2020.12

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  • AROによる研究推進体制

    戸高 浩司、中西 洋一

    Current Therapy   2018.5

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  • β遮断薬の慢性心不全に対する作用機序と治療戦略、今後の展望についてご教授ください

    戸高 浩司

    循環制御   2014.8

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    心不全の疾患概念はこれまで大きく変遷して来た。1960 年代までは浮腫性疾患とみなされ、浮腫を取る事が心不全の治療であった。ジギタリスを急速飽和し利尿を付けることを目指していた。 1980年代までは血行動態の異常が本体であると 再認識され、低下した心機能を上げることが治療の目標となった。各種強心薬が試されたが長期的には生命予後を悪化させる事が明らかとなった。 1990年代に入って低下した心機能により惹起された神経体液性異常が予後を悪化させていると 明らかになり主な治療対象となった。レ ニン・アンギオテンシン・アルドステロン系を抑制する ACE阻害剤が先に試され、その効果が確立した。

  • 未承認医療機器を用いた臨床研究実施の手引き

    川上浩司、中里適、北川雄光、清水公治、田上和夫、戸高浩司、松田公志、山本晴子、新井茂鉄、大庭和夫、上崎勇一、伴隆一、丸岡英二、渡辺一博

    医療機器産業戦略コンソーシアム(METIS)   2011.12

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  • 急性冠症候群に対する抗血栓薬 一わが国における新しい抗血栓薬の必要性は?:開発の現状

    戸高浩司

    「Heart View」Vol.13,No.11 p1272-8、メジカルビュー社   2009.11

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  • 慢性心不全患者の運動訓練による左室拡張能の改善

    戸高浩司、酒井喜久雄

    臨床研究奨励基金   2002.1

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  • スワン・ガンツカテーテルで何が分かるか

    戸高浩司、小柳左門

    ICUとCCU   1998.1

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  • Deep Learning of ECG for the Prediction of Postoperative Atrial Fibrillation Reviewed

    Takeshi Tohyama, Tomomi Ide, Masataka Ikeda, Takuya Nagata, Koshiro Tagawa, Masayuki Hirose, Kouta Funakoshi, Kazuo Sakamoto, Junji Kishimoto, Koji Todaka, Naoki Nakashima, Hiroyuki Tsutsui

    Circulation. Arrhythmia and electrophysiology   2023.2

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    DOI: 10.1161/CIRCEP.122.011579

  • 本邦における医師主導治験の役割について

    戸高 浩司

    日本臨床薬理学会学術総会抄録集   2022.11

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    2003年に薬事法が改正され「医師主導治験」という世界的に見ても特異な制度が始まった。製薬会社等が開発・治験を実施してくれない採算性の低い製品・適応に対して、医師が自ら薬事承認のための臨床試験を計画・設計・実施する。最終的にそのデータを製薬会社等が承認申請に用いるという本質的に捻れた仕組みを持ち、元々はドラッグラグ、デバイスラグ等を解消する手段の一つとして始められた。昨今は企業開発品の初期治験でさえアカデミアに任せ、ある程度医師主導治験で成績が出るまで様子見をするという企業が出て来ているのも事実である。7月時点のjRCTで実施中の未承認薬医師主導治験が43試験ある。うち15件(35&#37;)は研究資金等の提供組織として製薬企業も記載されている。適応外薬も同じく43試験あり、21件(49&#37;)は製薬企業も記載されている。AMED公募において「なぜ企業治験ではないのか?」としばしば問題となるが、市場性が低い製品の臨床開発をどこが負担して実施すべきかについて明確な基準が無く、未だコンセンサスは得られていない。

    リポジショニングでよく見受ける特許切れ成分の新作用機序が臨床ニーズを満たす場合、臨床現場で発したneeds pull開発として医療従事者の熱意で推進するものの、必ずしも市場が要求したmarket pullではないことから来る弊害もある。研究費を獲得して医師主導治験を実施し有効性を証明して、先発薬を適応拡大できたとしても、沢山ある後発薬と差別化が難しい。用途特許等で法的に保護する事は可能であるが、後発薬の適応外使用を止める実効性には乏しい。従って採算が取れる目処が無いなどの理由により企業が承認申請を請け負わない場合がある。国内であまねく使用できるようにするという医師主導治験の本来目的は出口で頓挫してしまう。米国では保険適用を伴った臨床使用が薬事承認範囲を超えてcompendiaという形で広く認められているため、適応拡大に限れば我が国の保険行政特有の問題と言える。

    制度開始から20年近くたち、ARO初めとして現場は医師主導治験に慣れてきたが上記のような弊害も目立つ。アカデミアも企業もこの特有な制度を今後どのように活用して行くのか、規制当局とともに再考する時期に来ている。

    DOI: 10.50993/jsptsuppl.43.0_4-c-s44-2

  • DPCデータを用いた心不全患者のリスク層別化を行う機械学習モデルの開発

    遠山岳詩, 井手友美, 池田昌隆, 加来秀隆, 円山信之, 松島将士, 船越公太, 岸本淳司, 戸高浩司, 筒井裕之

    日本心不全学会学術集会プログラム・抄録集   26th   2022

  • AROを有する医療機関の調査とその可能性

    戸高 浩司

    日本臨床薬理学会学術総会抄録集   2021.12

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    【目的】

    革新的なアカデミア発創薬のため整備されてきたAROは来年度から橋渡し認定事業が開始され新たな局面を迎える。AMED ARO機能推進事業の昨年度結果を中心に我が国におけるAROの多様性とその活用についてご紹介する。

    【方法】

    ARO機能を有すると考えられる病院に対し、リソース指標(FTE人数、人件費等)、成果指標(医師主導治験数、実用化製品数等)それぞれについて調査票形式による調査を実施した。

    【結果・考察】

    129の機関から有効な回答を得た。得られた調査票項目を57に縮約し、リソース、成果を敢えて区別することなく主成分分析を行った。臨床試験関連中間成果(企業治験等)が臨床試験支援人材(CRC等)と共に多くは上寄りに布置されており、第3主成分(y軸)上方向はエビデンス創出に関連した方向性を示していると考えられる。逆に臨床試験以外の中間成果(特許等)やライセンスアウトといった最終成果は、臨床試験関連以外の支援人材(プロジェクトマネージャ等)と共に多くが下寄りに位置しており、下方向は実用化指向を表していると解釈される。一方、横方向について第2主成分(x軸)では再生医療・医療機器や倫理指針試験等、コスト負担や個別対応を求められるような「創意工夫」が必要なリソース要求度の高い項目や獲得研究費が右に位置しており、高リソース要求容認を表していると判断される。逆に左には患者申出療養や医師主導治験などの規制の強い試験群とそれに必要な臨床試験実施関連のリソース(phase I施設等)が並んでおり規制が強いが定型的な業務として収益を上げやすく、比較的リソース投入がし易い方向性(収益性が高い)を示していると判断される。施設スコアについては昨年度と同じく第1主成分(規模)の小さなその他の病院が原点付近に集まり、結果的に平均的な特性になったと判断される。拠点やARO規模の大きな特定機能病院は負荷図に沿った特徴に従って外側寄りに分布していると解釈される。

    【結論】

    我が国のAROはエビデンス/実用化指向性、コスト容認/効率重視の方向性の違いにより大まかに分類され、拠点AROが特に特徴ある分布を示した。結果を利用してAROの特徴を可視化したポータルを作成し、研究者とAROのマッチングが容易となるよう公開した(https://www.aro-portal.com/ja/home)。本邦全体としてARO機能が広く整備され、橋渡し研究を目指す研究者に必要な支援が行き渡ることが肝要と考えられる。

    DOI: 10.50993/jsptsuppl.42.0_2-sps-4

  • 治験薬調剤時の逸脱防止に向けた取り組みとその有用性の評価

    高木 雅恵, 田島 壮一郎, 坂口 裕美, 長谷部 結衣, 田中 智佳, 田中 瑠美, 了戒 百合子, 中屋 純子, 西田 朋子, 戸高 浩司, 馬場 英司, 家入 一郎

    日本臨床薬理学会学術総会抄録集   2021.12

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  • 筋萎縮性側索硬化症に対する治療法開発を推進するための新規分類法の策定

    小早川 優子, 戸高 浩司, 橋本 侑, 山崎 亮, 吉良 潤一

    臨床神経学   2021.9

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  • 研究者主導臨床試験に望まれる安全性情報の取扱いについて

    高尾 結佳, 角田 千穂, 木村 真紀, 戸高 浩司

    臨床薬理   2021.1

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  • 筋萎縮性側索硬化症の予後を反映した新規分類法の策定

    小早川 優子, 戸高 浩司, 橋本 侑, 山崎 亮, 吉良 潤一

    日本難病医療ネットワーク学会機関誌   2020.11

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  • リアルワールドエビデンスを創出するための臨床中核指定病院ネットワークの取り組み パフォーマンス指標を現場にフィードバックすることで高齢者糖尿病医療の質を改善させる枠組みの構築

    船越 公太, 中村 泰三, 宮原 冬佳, 山下 貴範, 高田 敦史, 遠山 岳詩, 行実 郁子, 坂梨 健二, 野尻 千夏, 垣内 嘉, 高柳 直美, 園田 紀之, 中山 雅晴, 戸高 浩司, 馬場 英司, 中島 直樹

    医療情報学連合大会論文集   2020.11

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  • 標準化された医療情報の臨床研究への活用

    木島 真一, 永富 祐太, 中村 泰三, 坂梨 健二, 船越 公太, 日浅 謙一, 的場 哲哉, 井手 友美, 行実 郁子, 高田 敦史, 山下 貴範, 戸高 浩司, 馬場 英司, 筒井 裕之, 中島 直樹

    医療情報学連合大会論文集   2020.11

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  • 筋萎縮性側索硬化症の予後を反映した新規分類法の策定

    小早川 優子, 戸高 浩司, 橋本 侑, 山崎 亮, 吉良 潤一

    日本難病看護学会誌   2020.10

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  • AROを具体的事例より考える:科学的なエビデンスの確立とAROの多様性 我が国のAROの多様性について ARO機能推進事業

    戸高 浩司

    臨床薬理   2020.10

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  • Reports from Frontline 九州大学における橋渡し研究,精密医療の開発について—Translational research and precision medicine development in Kyushu University

    戸高 浩司

    Precision medicine = プレシジョンメディシン / 「Precision medicine」編集委員会 編   2020.10

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  • AIによる循環器専門医レベルのワーファリン投与量調整(Experienced Cardiologist-Level Dose Adjustment of Warfarin Using Artificial Intelligence)

    福島 孝紘, 遠山 岳詩, 船越 公太, 井手 友美, 戸高 浩司, 筒井 裕之

    日本循環器学会学術集会抄録集   2020.7

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  • 臨床研究中核病院で標準化された医療情報の臨床研究利用 電子カルテデータのREDCapとCRIN-Qへの連携

    坂梨 健二, 木島 真一, 山下 貴範, 吉田 尚生, 奥井 佑, 船越 公太, 戸高 浩司, 馬場 英司, 中島 直樹

    医療情報学連合大会論文集   2019.11

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  • ALSに対する臨床試験の対象患者群の設定に関する現状と問題点

    小早川 優子, 戸高 浩司, 白石 渉, 山崎 亮, 吉良 潤一

    日本難病医療ネットワーク学会機関誌   2019.11

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  • ポジショニング分析を用いた本邦AROの類型化

    戸高 浩司, 遠山 岳詩, 船越 公太, 岸本 淳司

    臨床薬理   2019.11

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  • クラスタリング分析による拡張型心筋症の形態学的表現型分析 日本の難病データベースからの知見(Morphological Phenotyping of Dilated Cardiomyopathy by Clustering Analysis: Insight from Japanese Intractable Disease Database)

    船越 公太, 加耒 秀隆, 遠山 岳詩, 戸高 浩司, 井手 友美, 筒井 裕之

    日本循環器学会学術集会抄録集   2019.3

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  • クッシングレジストリの構築と11βHSD-type1阻害薬の治療効果の検討

    織田 聡子, 永田 宙生, 坂本 昌平, 坂本 竜一, 小川 佳宏, 内山 麻希子, 戸高 浩司, 中西 洋一, 蘆田 健二, 野村 政壽

    日本内分泌学会雑誌   2018.12

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  • 【ドラッグリポジショニング-新たな治療戦略】AROによる研究推進体制

    戸高 浩司, 中西 洋一

    カレントテラピー   2018.5

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  • Cushing症候群の病態解明と薬物治療

    蘆田 健二, 織田 聡子, 永田 宙生, 内田 麻希子, 戸高 浩司, 小川 佳宏, 野村 政壽

    日本内分泌学会雑誌   2018.4

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  • 臨床研究と医薬品等開発のポイント

    戸高 浩司

    日本小児麻酔学会誌   2017.8

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  • 第1部 臨床研究の基礎講座 2.臨床研究と開発:Academic Research Organizationの役割

    戸高 浩司

    日本臨床外科学会雑誌   2016.5

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    CLINICAL STUDY AND MEDICAL PRODUCT DEVELOPMENT:ROLE OF THE ACADEMIC RESEARCH ORGANIZATION

    DOI: 10.3919/jjsa.77.1292

  • 臨床研究と開発 : Academic Research Organizationの役割—CLINICAL STUDY AND MEDICAL PRODUCT DEVELOPMENT : ROLE OF THE ACADEMIC RESEARCH ORGANIZATION—臨床研究セミナー記録 日本外科学会・日本臨床外科学会共催(第77回日本臨床外科学会総会開催時) 第15回臨床研究セミナー ; 第1部 臨床研究の基礎講座

    戸高 浩司

    日本外科学会雑誌 = Journal of Japan Surgical Society / 日本外科学会 編   2016.3

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  • β遮断薬の慢性心不全に対する作用機序と治療戦略、今後の展望についてご教授ください

    戸高 浩司

    循環制御   2015.2

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    DOI: 10.11312/ccm.35.177

  • 第45回日本生体医工学会

    戸高 浩司

    循環制御 = CIRCULATION CONTROL   2006.9

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  • Do we need combination products?

    戸高 浩司

    Clin Therap Med 22   2006.8

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  • 我が国における新薬開発をよりよくするために―現状の問題点と解決を探る―1. 日本の新薬開発は特殊なのか?

    戸高 浩司

    臨床薬理   2006.4

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    DOI: 10.3999/jscpt.37.4_69s

  • 92)運動時に左室流出路狭窄が誘発され胸痛をきたした,左室肥大を伴わないS状中隔の一例(第99回日本循環器学会九州地方会)

    福山 香詠, 長澤 志麻子, 戸高 浩司, 砂川 賢二

    2006.4

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  • 98)経過中に無痛性甲状腺炎を合併し,心不全増悪を来たした拡張型心筋症の一例(第99回日本循環器学会九州地方会)

    工藤 恭子, 高橋 優, 戸高 浩司, 砂川 賢二

    2006.4

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  • 予測予防対応型の医薬品安全監視計画

    戸高 浩司

    Jpn Pharmacol Ther 33   2005.9

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  • 73) 劇症型心筋炎に続発性ヘモクロマトーシスを併発した一例(日本循環器学会 第90回九州地方会)

    宮下 要, 戸高 浩司, 岡部 眞典, 山本 雄祐

    2001.10

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  • 留学速報

    戸高浩司

    循環制御   1997.9

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    Division of Circulatory Physiology, Department of Medicine, College of Physicians & Surgeons, Columbia University in the City of New York, USA

  • 心臓の負荷整合と最適効率

    戸高浩司

    心臓の適応と制御   1992.7

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  • トレッドミル運動負荷試験におけるST再低下の意義(日本循環器学会 第69回九州地方会)

    久納 隆一, 満岡 渉, 戸高 浩司, 久富 誠恵

    1992.7

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    Language:Japanese  

  • シリーズ17「血管疾患を診る」−生理から見た血管疾患

    戸高浩司、竹下彰

    「心臓病診療プラクティス」高木眞一・松尾汎編、文光堂   1990.1

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    Language:Japanese   Publishing type:Article, review, commentary, editorial, etc. (scientific journal)  

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Professional Memberships

  • The Japanese Society of Internal Medicine

  • The Japanese Circulation Society

  • Japanese Heart Failure Society

  • Japanese Society of Clinical Pharmacology and Therapeutics

  • Japanese Society for Medical and Biological Engineering

  • SOCIETY FOR REGULATORY SCIENCE OF MEDICAL PRODUCTS

  • Japan Society of Clinical Trials and Research

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Committee Memberships

  • ARO協議会   Executive   Domestic

    2022.4 - Present   

  • 日本循環器学会   FJCS, Fellow of Japanese Circulation Society   Domestic

    2022.4 - Present   

  • ARO協議会   設立時社員   Domestic

    2022.4 - Present   

  • 日本循環器学会   Steering committee member   Domestic

    2020.7 - 2023.5   

  • 日本循環器学会   倫理委員会   Domestic

    2020.7 - 2023.5   

  • 医薬品医療機器レギュラトリーサイエンス財団   レギュラトリーサイエンス エキス パート研修会 医療機器アドバイザリーグループ   Domestic

    2020.2 - Present   

  • レギュラトリーサイエンス学会   Councilor   Domestic

    2013.11 - 2018.9   

  • 日本生体医工学会   associate editor   Domestic

    2013.10 - 2019.3   

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Academic Activities

  • 座長(Chairmanship)

    ARO協議会  ( Japan ) 2023.8

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    Type:Competition, symposium, etc. 

  • 座長(Chairmanship)

    臨床薬理学会 九州地方会  ( Japan ) 2023.7

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    Type:Competition, symposium, etc. 

  • 先進医療技術審査部会 委員

    Role(s): Review, evaluation

    厚生労働省  2022.4 - 2022.12

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    Type:Scientific advice/Review 

  • Screening of academic papers

    Role(s): Peer review

    2022

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    Type:Peer review 

    Number of peer-reviewed articles in foreign language journals:3

  • Screening of academic papers

    Role(s): Peer review

    2021

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    Type:Peer review 

    Number of peer-reviewed articles in Japanese journals:1

  • 座長(Chairmanship)

    国際共同臨床研究推進シンポジウム  ( Japan ) 2020.2

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    Type:Competition, symposium, etc. 

  • Screening of academic papers

    Role(s): Peer review

    2020

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    Type:Peer review 

    Proceedings of domestic conference Number of peer-reviewed papers:3

  • 患者申出療養に係る検討委員会

    Role(s): Review, evaluation

    厚生労働省  2019.12 - Present

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    Type:Scientific advice/Review 

  • Screening of academic papers

    Role(s): Peer review

    2019

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    Type:Peer review 

    Number of peer-reviewed articles in foreign language journals:1

  • 医療機器開発マネジメントチェック項目 策定WG

    Role(s): Review, evaluation

    日本医療研究開発機構  2018.6 - 2019.3

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    Type:Scientific advice/Review 

  • Screening of academic papers

    Role(s): Peer review

    2018

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    Type:Peer review 

    Number of peer-reviewed articles in foreign language journals:1

  • Screening of academic papers

    Role(s): Peer review

    2017

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    Type:Peer review 

    Number of peer-reviewed articles in foreign language journals:1

  • 医療機器開発推進研究事業 課題評価委員

    Role(s): Review, evaluation

    日本医療研究開発機構  2016.1 - Present

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    Type:Scientific advice/Review 

  • 循環器疾患・糖尿病等生活習慣病対策実用化研究事業 課題評価委員

    Role(s): Review, evaluation

    日本医療研究開発機構  2015.9 - Present

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    Type:Scientific advice/Review 

  • 医療機器等開発・事業化支援プラットフォーム専門家

    Role(s): Review, evaluation

    九州産業技術センター 経済産業省九州経産局  2014.10 - 2015.3

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    Type:Scientific advice/Review 

  • 和文誌・生体医工学、英文誌・Advanced Biomedical Engineering (ABE) International contribution

    2013.10 - 2019.3

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    Type:Academic society, research group, etc. 

  • プログラム委員 International contribution

    HBD Thinktank East  ( Tokyo Women's Medical University Japan ) 2013.7

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    Type:Competition, symposium, etc. 

    Number of participants:1,000

  • 座長(Chairmanship)

    臨床薬理学会  ( Japan ) 2012.11 - 2012.12

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    Type:Competition, symposium, etc. 

  • 座長(Chairmanship)

    日本生体医工学会  ( Japan ) 2012.5

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    Type:Competition, symposium, etc. 

  • 課題解決型医療機器の開発・改良に向けた病院・企業間の連携支援事業

    Role(s): Review, evaluation

    経済産業省  2011.2 - 2015.3

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    Type:Scientific advice/Review 

  • 医療技術産業戦略コンソーシアム「戦略会議」委員

    Role(s): Review, evaluation

    医療技術産業戦略コンソーシアム  2008.4 - 2009.3

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    Type:Scientific advice/Review 

  • 座長(Chairmanship)

    第7回日本心血管カテーテル治療学会学術集会  ( Japan ) 2007.8

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    Type:Competition, symposium, etc. 

  • 座長(Chairmanship)

    日本循環器学会九州地方会  ( Japan ) 2007.6

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    Type:Competition, symposium, etc. 

  • 日本学術振興会審査委員候補

    Role(s): Review, evaluation

    日本学術振興会  2007.4 - Present

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    Type:Scientific advice/Review 

  • 座長(Chairmanship)

    日本内科学会九州地方会  ( Japan ) 2007.1

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    Type:Competition, symposium, etc. 

  • 座長(Chairmanship) International contribution

    第45回日本生体医工学会  ( Japan ) 2006.5

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    Type:Competition, symposium, etc. 

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Other

  • 非接触式迷走神経刺激による急性冠症候群治療機器の評価指標 Ver. 3.1

    2017.2

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    我が国における急性冠症候群死亡率は、救命救急体制(冠動脈疾患ユニット(CCU)、経皮的冠動脈インターベンション(PCI)等)の構築・普及により近年大きく減少した。しかしながら、診断の遅れ等により発症から病院到達までに時間がかかる場合や、側副血行路が無い症例、再灌流障害例等では、急性期の救命には成功しても広範な心筋壊死を伴い、心不全を惹起、長期予後不良となる症例が存在する。現状では可能な限り早期に再灌流する以外には、薬剤、手術手技を含めて梗塞サイズを縮小する有効な手段はない。
     近年、急性心筋梗塞動物モデル(虚血再灌流)において迷走神経刺激が梗塞サイズを縮小し、生命予後を大きく改善する事が示された1-2。ヒトにおいても難治性てんかんに対する植え込み型迷走神経刺激装置があるほか、慢性心不全を対象とした植込み型迷走神経刺激装置の臨床試験が行われている3-5。しかしながら、これらは植え込み型であるために急性冠症候群のような急性期治療には応用できない。
     現在開発中の非接触式迷走神経磁気刺激装置を用いることで、救急医療の現場で速やかに且つ非侵襲的に迷走神経を刺激することが可能となり、上記の効果を上げると期待されており、類似機器を急性期に用いる際の参考ともなるため、今回評価指標の整備を行う。
     なお、本評価指標は治療機器として求められる有効性及び安全性の事項を中心にまとめたものであるが、開発する治療機器について、我が国の医療機器薬事承認を得るためには、関連通知6-9に示されるとおり、倫理性、科学性及び信頼性の確保された資料より、医療機器としての品質、有効性及び安全性を立証するための十分な根拠が示される必要がある。

Research Projects

  • 感染症緊急事態に対応するためのアジア諸国および本邦アカデミアとの国際ARO アライアンスの機能強化、および関連機関との連携システム構築

    2023.4 - 2026.3

    AMED 

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    Authorship:Coinvestigator(s) 

    ARISEを主体として機能強化を図る。加盟施設と6つのワーキンググループでの議論を元に、新たに戦略的な委員会を設置する。産官学民連携戦略推進委員会は、各国の試験実施機関の調査・分析、施設・KOL等の特定、PMDAとのワークショップ、 NCGM国際感染症フォーラムとの連携、政策提言、JICAとの関係強化や役割構築を進める。国際研究開発戦略推進委員会は、新興国等におけるE17実現のためのMRCTデザイン、ARISEにおけるCOVID-19リカバリ試験プロトコルをデザイン・試験を実施するために必要な課題を抽出し、提言をまとめる。国際研究基盤戦略推進委員会は、各国における臨床研究人材育成状況調査、アジア各国における臨床研究専門家人材育成にかかる政策提言、各専門家に必要な研修プログラムの策定及び認証制度を設計する。なお、本事業は、緊急時対応を念頭に置いたものであるが、平時における臨床開発やEBMの企画実施能力の向上にも繋がっており、今パンデミックのみならず、サイレントパンデミックと言われるAMRや顧みられない熱帯病等、他の疾患への貢献にも努める。

  • 標準化電子ワークシートを核とした分散型臨床試験のシステム・運用両面からの構築

    2022.7 - 2023.3

    AMED 

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    Authorship:Principal investigator 

  • 「総合知」を結集したトランスディシプリナリー型異分野融合研究基盤の創出

    Grant number:22ym0126816j0001  2022 - 2024

    Grants-in-Aid for Scientific Research  橋渡し研究プログラム

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 標準化電子ワークシートを核とした分散型臨床試験のシステム・運用両面からの構築

    2022

    Grants-in-Aid for Scientific Research  医療研究開発推進事業費

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    Authorship:Principal investigator  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 九州大学先端医療オープンイノベーションセンターは、アジアの橋渡し研究推進拠点として、ネットワーク対応型の開発を推進しています。これまで、産学共同研究は学術的な観点では多くの成果をあげてきました。しかしながら、実用化に至る事例が多くない状況を鑑みると、新しいオープンイノベーション戦略が必要です。本共同研究部門では、日本医療研究開発機構も推奨する、「産」in「学」の新しい形を目指して、持田製薬の創薬アセットと当センターが保有するネットワークをフル活用し、社会実装につながる開発指向の高い共同研究を展開します。

    2021.6 - 2024.3

    Joint research

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    Authorship:Principal investigator  Grant type:Other funds from industry-academia collaboration

  • レセプトデータを基軸としたデータ駆動型臨床疫学研究の基盤開発

    2020.4 - 2023.3

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  • レジストリを活用した慢性血栓塞栓性肺高血圧症に対するエドキサバンの適応拡大のための第III相医師主導治験

    2020.4 - 2023.3

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  • リパスジルを用いた未熟児網膜症に対する新規点眼薬の開発

    2020.4 - 2023.3

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  • ICH-GCP 改定における国内ステークホルダーの参画のための研究 International coauthorship

    2020.4 - 2021.3

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  • シーズ開発実績に裏付けられたARO機能のリソース次元縮約と可視化に関する研究

    2020.4 - 2021.3

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    Authorship:Principal investigator 

    The applicant group conducted a study on the resources and results of 109 ARO facilities nationwide through the ARO Function Evaluation Project and obtained the following conclusions.
    a) Resources and outcomes are positively correlated but vary widely
    b) ARO intermediate results are classified into four indicators according to purpose
    1. Early development of IP and regulatory strategies
    2. Quasi-Pivotal trial design construction and execution
    3. Conduct safe clinical research and provide advanced medical care
    4. Human resource development and sustainability
    c) From the viewpoint of the efficiency of practical application such as approval, the level of resources (intellectual property charge, etc.) other than the clinical trials related to b) 1 above will lead to higher results (patents, etc.)

    These are the results of cross-sectional surveys as of 2019, and it is necessary to procpectively verify whether short-term results such as trials will lead to outcomes such as approval and provision of new medical care over the medium to long term.
    For this reason, a revised questionnaire will be created to narrow down the items, and a continuous survey will be conducted. The following resource list is updated at the same time as the change over time is grasped.

    A. Supporter's perspective
    Although ARO's detailed resource list has been prepared as an A-Concierge (MEXT), input has been weak and has not been used due to resistance to registration of personal occupations. On the other hand, in this proposal, it is possible to create a necessary and sufficient and up-to-date quantitative list of resources on human and material accounts from the above survey.
    Because it is a self-report, the effectiveness is secured by the following method.
    The "base support seeds information" registered by the base in AMED and the trial results of the above questionnaire, etc., as real data, provide strong support for support capabilities and specialty fields. With the consent, extract and transfer only the necessary data to a third-party organization, and then reduce and categorize the dimensions. At the same time, the number of seeds supported by type (products such as pharmaceuticals, medical devices, and regenerative medicine) In other words, quantify the “degree of specialty”.
    If a quantitative resource list and the "degree of specialty" based on the results that support it are presented at the same time, it becomes clear at a glance which ARO should be requested from a researcher.

    B. Perspective of support requester
    Researchers' requests for support vary depending on the characteristics of seeds, but in most cases they can be categorized as in the following example.

    Formulation of R & D strategy
    Formulation of intellectual property strategy
    Protocol creation support
    Statistical analysis design
    Data management
    Clinical trial support

    For these, a questionnaire survey will be conducted for researchers who have seeds. After analysis, the result is reflected in the support resource list and the support content evaluation.

  • レセプトデータを基軸としたデータ駆動型臨床疫学研究の基盤開発

    Grant number:20H00563  2020 - 2023

    Japan Society for the Promotion of Science  Grants-in-Aid for Scientific Research  Grant-in-Aid for Scientific Research (C)

    福田 治久, 能登 真一, 東 尚弘, 石黒 智恵子, 北村 哲久, 戸高 浩司, 小野 玲, 中島 直樹, 船越 公太, 土井 剛彦, 鴨打 正浩, 後藤 温, 井手 友美, 熊谷 成将

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    Grant type:Scientific research funding

    本研究の目的は,臨床的・政策的に真に貢献可能なエビデンスを創出できるデータ駆動型臨床疫学研究の基盤を構築することである.そのために,研究代表者が自治体と共同研究をしているLongevity Improvement & Fair Evidence Study(LIFE Study)において収集しているレセプトデータを基軸に,行政・学会・医療施設が保有する詳細な患者レジストリデータをリンケージしたデータベースを開発する.それにより各DBが相補的・相乗的な効果を発揮し,かつてない規模の臨床疫学研究が実施可能になり,将来の国家的データベース事業へ昇華させるためのモデルケースを確立する.

    CiNii Research

  • リパスジルを用いた未熟児網膜症に対する新規点眼薬の開発

    2020 - 2023

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • レジストリを活用した慢性血栓塞栓性肺高血圧症に対するエドキサバンの適応拡大のための第III相医師主導治験

    2020 - 2023

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費 難治性疾患等実用化研究事業 難治性疾患実用化研究事業

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • シーズ開発実績に裏付けられたARO機能のリソース次元縮約と可視化に関する研究

    2020

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費 ARO機能推進事業

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    Authorship:Principal investigator  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 神経変性疾患の病期に着目した治療法開発および承認後適正使用を推進する新規評価法の確立

    2019.6 - 2022.3

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    Authorship:Coinvestigator(s) 

    神経変性疾患に対する新規治療法の開発を円滑化し、実用化と承認後適正使用を推進する病期分類を提案する。

  • 多施設レジストリを活用し、慢性血栓塞栓性肺高血圧症に対するエドキサバンの適応拡大を目指すコンセプト策定研究

    2019.4 - 2020.3

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    Authorship:Coinvestigator(s) 

  • 神経変性疾患の病期に着目した治療法開発および承認後適正使用を推進する新規評価法の確立

    2019 - 2021

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 多施設レジストリを活用し、慢性血栓栓塞性肺高血圧症に対するエドキサバン(DU-176b)の適応拡大を目指すコンセプト策定研究

    2019

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費 難治性疾患等実用化研究事業 難治性疾患実用化研究事業

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • ポジショニング分析および経験則分析によるARO機能類型化・評価指標創出のための調査研究

    2018.10 - 2020.3

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    Authorship:Principal investigator 

    In order to put the research seed technologies of universities into practical use, various functions (as major classification) as shown in Figure 1 are generally required. Translational Research Centers and Clinical Research Core Hospitals, so-called Centers, have these facilities, but individual resource allocation, unique fields are not evenly distributed. The ARO function typing that reflects them has not yet been systematically investigated. Last year, Mitsubishi Research Institute published the result of the major classification function survey of the “advanced treatment function hospitals” in this project but did not analyze it.
    Therefore, in order to categorize the ARO functions that leads to the creation of the evaluation scale this fiscal year, we will extract the service of 15 Centers based on the results of last year and also extract the lower classification of service functions from the table of charges etc. We will prepare survey forms by extracting important basic / nonclinical items, clinical items, etc. Survey on resource allocation (FTE, labor cost, etc.), output indicator (acquired research funds, number of patent applications, number of papers, etc.) related to functions using a questionnaire will be conducted at “advanced treatment hospitals” considered to have ARO function.
    The obtained data is analyzed and evaluated by the following two methods.
    1. Heuristic rule analysis: Experts who are good at ARO management are recruited through the ARO Council, National University Hospital Clinical Research Promotion Council, etc., and opinions are consolidated at the evaluation meeting. With several discussions, convergence of opinion, we classify ARO function empirically. The characteristics of ARO and meaningful outputs relationships are analyzed empirically by overviewing the whole.
    2. Positioning analysis: Positioning analyses such as principal component analysis, correspondence analysis, clustering, etc. for resource items, output items, and other ARO characteristics (national / private / NC, Kanto /Kansai / other areas, and objective typing without human intervention. By analyzing which outputs and which ARO function features are closer to each other on the mapping, we synthesize evaluation indexes that lead to good results for AROs of Centers or other sites separately (Fig. 2).
    At the same time, we investigate the minimum information for mapping ARO’s overseas in the same coordinates, and analyze their position and contrast characteristics.
    After comparing and examining the methods 1 and 2, we propose the evaluation index which indicates strong correlation with functional classification and output in a meaningful way from the academic standpoint.

  • 本共同研究部門は、がん免疫分野における非臨床POC*の取得に関わる創薬支援と新日本科学で実施されるがん免疫に関する基礎研究に九州大学から得られる様々な知見を反映できるようサポートします。 九州大学病院は日本を代表する国立総合病院の一つであり、がんに関わらず日々多くの疾患に対する治療を提供しています。 同じキャンパス内の先端医療オープンイノベーションセンターに本共同研究部門が設立されたことによって、同大学病院から生み出されるがん領域における様々な研究成果と新日本科学が長年に渡り培ってきた非臨床領域におけるノウハウを結びつけることが可能になります。 九州大学と新日本科学との共同研究の成果により、将来的にがん患者の皆様に一つでも多く、治療の選択肢を提供できるような研究結果が得られるよう貢献して参ります。

    2018.4 - 2025.3

    Joint research

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    Authorship:Principal investigator  Grant type:Other funds from industry-academia collaboration

  • 高機能データベースを用いた先天性心疾患患者のための包括的看護支援システムの構築

    2018.4 - 2021.3

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    Authorship:Coinvestigator(s) 

  • 慢性血栓塞栓性肺高血圧症の抗凝固療法に関するレジストリ構築研究

    2018.4 - 2021.3

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    Authorship:Coinvestigator(s) 

    目的:CTEPHにおける抗凝固療法の有効性・安全性評価に係る基盤構築と新規抗凝固薬の有効性・安全性の評価
    デザイン:多施設共同、レジストリ、観察研究
    対象:CTEPH患者、もしくはCTEPH治療後(血栓摘除術後、バルーン肺動脈拡張術後)の患者
    目標症例数:200症例(DOAC を20%含む)と想定
    (設定根拠:本レジストリは探索的であり、基盤となることを目的としており、症例数の上限は設けない)

  • 次世代シークエンサーによる網羅的がん関連遺伝子パネル解析を用いたHER2遺伝子変異陽性の進行非小細胞肺癌に対する治療開発を目指した研究

    2018.4 - 2021.3

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    Authorship:Coinvestigator(s) 

  • 網膜色素変性に対する視細胞保護遺伝子治療の医師主導治験

    2018.4 - 2021.3

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  • 慢性血栓塞栓性肺高血圧症に関する多施設共同レジストリ研究

    2018.4 - 2021.3

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    Authorship:Coinvestigator(s) 

  • 高機能データベースを用いた先天性心疾患患者のための包括的看護支援システムの構築

    Grant number:18H03083  2018 - 2020

    Japan Society for the Promotion of Science  Grants-in-Aid for Scientific Research  Grant-in-Aid for Scientific Research (C)

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    Grant type:Scientific research funding

  • 次世代シークエンサーによる網羅的がん関連遺伝子パネル解析を用いたHER2遺伝子変異陽性の進行非小細胞肺癌に対する治療開発を目指した研究

    2018 - 2020

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • ナチュラルキラーT細胞活性化による慢性炎症制御に基づく新たな心筋症治療の実用化

    2018 - 2020

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費 難治性疾患等実用化研究事業 難治性疾患実用化研究事業

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 網膜色素変性に対する視細胞保護遺伝子治療の医師主導治験

    2018 - 2020

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費 難治性疾患等実用化研究事業 難治性疾患実用化研究事業

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 慢性血栓塞栓性肺高血圧症の抗凝固療法に関するレジストリ構築研究

    2018 - 2020

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費 難治性疾患等実用化研究事業 難治性疾患実用化研究事業

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • ポジショニング分析および経験則分析による ARO 機能類型化・評価指標創出のための 調査研究

    Grant number:19lk1903002h0002  2018 - 2019

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費 ARO機能評価事業

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    Authorship:Principal investigator  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 心不全患者の再入院を防止する革新的多機能血行動態モニタの臨床開発

    2017.6 - 2020.3

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    Authorship:Coinvestigator(s) 

    本研究開発では、呼吸状態と酸素飽和度の測定という非侵襲的要素の計測のみで、簡易・高精度に心 拍出量を測定し、病棟での重症心不全患者の質の高い診療のみならず、このような患者の外来診療・訪 問看護・在宅医療に使用することのできる「非侵襲小型心機能モニタ」の実現を目標とする。指尖(も しくは手首)に取り付けた光学センサから、脈波・酸素飽和度を測定し、これらの生体信号を基に、新た に考案したアルゴリズム(LFCT 法)を用いて血液循環時間を回帰計算する事で、カテーテルを用いなくと も、高精度に心拍出量を算出する。また、センサヘッドには日本オリジナルのレーザ技術である VCSEL(垂 直共振器型面発光レーザ)を用いて、高精度に生体情報を取得できる小型モニタリング装置の実現を目 指す。測定項目は、心拍出量に加え、循環機能を示す指標(酸素飽和度・脈拍数・血流量・呼吸波形) も同時に出力することで、極めて容易に患者の状態をより正確に把握することが出来る。

  • 支援体制の強化・効率化による革新的医療開発の迅速化

    2017.4 - 2025.3

    AMED 

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    Authorship:Principal investigator 

    「西部日本地域のシーズ研究開発支援を行う自立した中核病院拠点」の実現のために、被験者の安全性確保に係る体制を整備した上で、臨床研究支援体制を強化し、日本発の革新的な医療シーズ等をいち早く実用化に繋げる。九州大学 学術研究・産学官連携本部(AiRIMaQ)と医歯薬系以外のいわゆる異分野のシーズ情報を定期的に交換する場を創生する。科研費等の採択者を中心に研究室訪問し、知財の専門家による掘り起こしを継続する。臨床研究監理部門を設置、対応する事務所掌も再編し観察研究から治験に至るまで臨床研究全般の管理監督体制を強化する。

  • 心不全の発症・重症化の高精度予測とそれに基づく最適な治療戦略の開発

    2017.4 - 2020.3

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    心不全患者を対象としたデータベースを用いて、退院後の死亡または心不全による再入院を予測する因子を同定 する。既存のデータベース(JCARE 研究、NARA-HF 研究、JROAD など)を用いて古典的予測因子の有用性を検証す るとともに、さらに高精度の予測法を開発することを目的に古典的予測因子ばかりでなく新規の臨床情報やバイ オマーカーも含む広範な因子を網羅した多施設共同患者データベースを構築し、その有効性の検証を行う。
    <研究デザイン› 多施設共同前向きコホート研究(日本心不全学会の後援)
    <研究対象者›
    ●対象者:心不全の診断にて入院治療を行った患者 ●選択基準:フラミンガム基準に基づいた心不全症状と徴候 ●除外基準:心臓手術(心移植は除く)の予定されている患者、心不全以外の原因で余命が 1 年以内と想定され る患者

  • 支援体制の強化・効率化による革新的医療開発の迅速化

    2017 - 2024

    Grants-in-Aid for Scientific Research  医療研究開発推進事業費

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    Authorship:Principal investigator  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 心不全患者の再入院を防止する革新的多機能血行動態モニタの臨床開発

    2017 - 2019

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費 医療分野研究成果展開事業

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 心不全の発症・重症化の高精度予測とそれに基づく最適な治療戦略の開発

    2017 - 2019

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費 循環器疾患・糖尿病等生活習慣病対策実用化研究事業

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 医薬品開発に利用できる疾患領域別データ標準の作成に関する研究

    2016 - 2018

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費 医薬品等規制緩和・評価研究事業

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 患者レジストリを活用した難治性クッシング症候群及びサブクリニカルクッシング症候群の病態解明と11β-HSD1阻害剤の臨床開発

    2016 - 2018

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費 臨床研究・治験推進研究事業

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 心筋梗塞後心不全を防ぐ迷走神経刺激カテーテル装置開発

    2016 - 2018

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費 先端計測分析技術・機器開発プログラム

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • ウェアラブルモニターで実現する循環器診断支援技術の開発

    2015 - 2018

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費 未来医療を実現する医療機器・システム研究開発事業

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 先天性心疾患の患者教育とトータルライフケアをめざした医療情報集約システムの構築

    2015 - 2017

    Grants-in-Aid for Scientific Research  Grants-in-Aid for Scientific Research (Ministry of Health, Labour and Welfare)

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 網膜色素変性に対する視細胞保護遺伝子治療の実用化に関する研究~医師主導治験への移行を目指した研究~

    2015 - 2017

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費 難治性疾患実用化研究事業

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • ナチュラルキラーT細胞活性化による慢性炎症制御に基づく新たな心筋症治療の実用化

    2015 - 2017

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費 難治性疾患実用化研究事業

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 重症肺高血圧症の予後と生活の質を改善するための安心安全のナノ医療製剤(希少疾病用医薬品)の実用化臨床試験

    2015 - 2017

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費 難治性疾患実用化研究事業

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 網膜色素変性に対する視細胞保護遺伝子治療臨床研究~GCPに準拠した遺伝子治療臨床研究~

    2015 - 2016

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費 医療技術実用化総合研究事業

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 高性能国産新規RNAウイルスベクターによる虚血肢治療製剤の開発

    2015 - 2016

    Grants-in-Aid for Scientific Research  日本医療研究開発機構研究費 医療技術実用化総合研究事業

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 革新的医薬品・医療機器・再生医療製品実用化促進事業(循環器疾患、次世代型治療機器)

    2012 - 2016

    Grants-in-Aid for Scientific Research  Grants-in-Aid for Scientific Research (Ministry of Health, Labour and Welfare)

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • レギュラトリーサイエンスの手法を用いた新薬承認審査ナレッジベースの構築と応用

    Grant number:23590603  2011 - 2013

    Japan Society for the Promotion of Science  Grants-in-Aid for Scientific Research  Grant-in-Aid for Scientific Research (C)

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    Grant type:Scientific research funding

  • レギュラトリーサイエンスの手法を用いた新薬承認審査ナレッジベースの構築と応用

    2011 - 2013

    Japan Society for the Promotion of Science  Grants-in-Aid for Scientific Research  Grant-in-Aid for Scientific Research (C)

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    Authorship:Coinvestigator(s)  Grant type:Scientific research funding

  • コンパニオン体外診断用医薬品の臨床性能試験の在り方に関する再帰的研究

    2011 - 2013

    Grants-in-Aid for Scientific Research  Grants-in-Aid for Scientific Research (Ministry of Health, Labour and Welfare)

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • デバイス・ラグ解消に向けた海外規制の実態とその対策に係る調査研究

    2011 - 2012

    Grants-in-Aid for Scientific Research  Grants-in-Aid for Scientific Research (Ministry of Health, Labour and Welfare)

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    Authorship:Principal investigator  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 医療機器の国際的な動向を踏まえた品質、有効性及び安全性の評価に関する研究

    Grant number:19014  2007 - 2009

    Grants-in-Aid for Scientific Research  Grants-in-Aid for Scientific Research (Ministry of Health, Labour and Welfare)

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 脊随損傷患者の血圧調節失調を克服するためのバイオニック血圧制御システムの開発

    Grant number:18100006  2006 - 2010

    Japan Society for the Promotion of Science  Grants-in-Aid for Scientific Research  Grant-in-Aid for Scientific Research (C)

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    Grant type:Scientific research funding

  • 心筋収縮能に関連する新たな磁気共鳴パラメータの開発

    Grant number:18591353  2006 - 2008

    Japan Society for the Promotion of Science  Grants-in-Aid for Scientific Research  Grant-in-Aid for Scientific Research (C)

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    Grant type:Scientific research funding

  • 循環器疾患領域における大規模臨床試験の手法に係る研究

    Grant number:H18-tokubetsu-sitei-010  2006

    Grants-in-Aid for Scientific Research  Grants-in-Aid for Scientific Research (Ministry of Health, Labour and Welfare)

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

  • 日本人急性冠症候群における冠動脈形成術前スタチン投与の有効性に関する臨床疫学研究

    Grant number:17606004  2005 - 2006

    Japan Society for the Promotion of Science  Grants-in-Aid for Scientific Research  Grant-in-Aid for Scientific Research (C)

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    Grant type:Scientific research funding

  • 日本人急性冠症候群における冠動脈形成術前スタチン投与の有効性に関する臨床疫学研究

    Grant number:17606004  2005 - 2006

    Japan Society for the Promotion of Science  Grants-in-Aid for Scientific Research  Grant-in-Aid for Scientific Research (C)

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    Authorship:Principal investigator  Grant type:Scientific research funding

  • 次世代医療機器研究・開発・商業化促進のための薬事承認の在り方に関する研究

    Grant number:H16-tokubetsu-037  2004

    Grants-in-Aid for Scientific Research  Grants-in-Aid for Scientific Research (Ministry of Health, Labour and Welfare)

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    Authorship:Coinvestigator(s)  Grant type:Competitive funding other than Grants-in-Aid for Scientific Research

▼display all

Educational Activities

  • 全学対象の基幹教育カリキュラム総合科目「医療イノベーション ー未来を一緒に作ろうー」、医学研究院大学院「トランスレーショナルリサーチの推進体制とその現状」の講義を担当している。
    その他、臨床研究、倫理、橋渡し研究などの専門スタッフ向け教育を学内外で数多く担当している。

Class subject

  • トランスレーショナルリサーチの推進体制とその現状

    2024.10 - 2025.3   Second semester

  • 医療イノベーション-未来の医療を一緒に作ろう-

    2024.10 - 2024.12   Fall quarter

  • 医薬品・医療機器開発と治験

    2024.6 - 2024.8   Summer quarter

  • 医療イノベーション-未来の医療を一緒に作ろう-

    2023.10 - 2023.12   Fall quarter

  • 医療イノベーション-未来の医療を一緒に作ろう-

    2022.10 - 2022.12   Fall quarter

  • 医薬品・医療機器開発と治験

    2022.6 - 2022.8   Summer quarter

  • 医薬品・医療機器開発と治験

    2022.4 - 2022.9   First semester

  • 医療イノベーション

    2021.10 - 2022.3   Second semester

  • トランスレーショナルリサーチの推進体制とその現状

    2021.10 - 2022.3   Second semester

  • 医療イノベーション

    2020.10 - 2021.3   Second semester

  • トランスレーショナルリサーチの推進体制とその現状

    2020.10 - 2021.3   Second semester

  • 総合医学VII 医療イノベーション科目I

    2018.10 - 2019.3   Second semester

  • 明日の医療を創るしくみ

    2018.4 - 2018.9   First semester

  • 総合医学VII 医療イノベーション科目I

    2017.10 - 2018.3   Second semester

  • 明日の医療を創るしくみ

    2017.4 - 2017.9   First semester

  • 総合医学VII 医療イノベーション科目II

    2016.10 - 2017.3   Second semester

  • 明日の医療を創るしくみ

    2016.4 - 2016.9   First semester

  • 総合医学VII 医療イノベーション科目I

    2015.10 - 2016.3   Second semester

  • 医薬品・医療機器開発概論

    2015.4 - 2015.9   First semester

  • 総合医学VII 医療イノベーション

    2014.10 - 2015.3   Second semester

  • 総合医学VII 医療イノベーション

    2013.10 - 2014.3   Second semester

  • 大学院医学系学府博士課程 臨床研究専門教育科目

    2012.10 - 2013.3   Second semester

  • 臨床医学群 循環器

    2007.10 - 2008.3   Second semester

  • 大学院医学系学府博士課程 臨床研究専門教育科目

    2007.10 - 2008.3   Second semester

  • 大学院医学系学府医科学専攻修士課程、医療経営・管理学専攻専門職学位課程 病態制御学III-① 循環器概論

    2007.4 - 2007.9   First semester

  • 歯学部 内科学・外科学 循環器概論

    2007.4 - 2007.9   First semester

  • 臨床医学群 循環器

    2006.10 - 2007.3   Second semester

  • 保健学科

    2006.4 - 2006.9   First semester

  • 臨床医学群 循環器

    2005.10 - 2006.3   Second semester

  • 医療イノベーション-未来の医療を一緒に作ろう-

    2024.10 - 2024.12   Fall quarter

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Participation in international educational events, etc.

  • 2020.10

    The Clinical Research Initiative for Global Health

    THIRD CRIGH General Assembly

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    Venue:online

    Number of participants:100

  • 2019.11

    AHA

    AHA2019, American Heart Association Scientific Sessions Meeting

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    Venue:Philadelphia, PA, USA

    Number of participants:14,000

  • 2019.11

    厚生労働省、PMDA、FDA

    HBD East 2019 Think Tank Meeting

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    Venue:東京

    Number of participants:500

  • 2019.6

    CRIGH, The Clinical Research Initiative for Global Health

    The second CRIGH General Assembly

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    Venue:Paris, France

    Number of participants:100

  • 2019.6

    ARO council

    4th Global ARO Network Workshop

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    Venue:Paris, France

    Number of participants:100

  • 2017.11

    ARO council

    2nd Global ARO Network Workshop

      More details

    Venue:Austin, TX, USA

    Number of participants:100

  • 2016.4

    Samsung Medical Center

    Japan-Korea Joint Forum 2016

      More details

    Venue:Seoul, Korea

    Number of participants:200

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Other educational activity and Special note

  • 2023  Coaching of Students' Association  医学部情報研(旧medical innovation club)

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    顧問

  • 2022  Coaching of Students' Association  medical innovation club

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    顧問

  • 2021  Coaching of Students' Association  medical innovation club

     詳細を見る

    顧問

  • 2020  Special Affairs  厚生労働省 臨床研究・治験従事者研修

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    厚生労働省 臨床研究・治験従事者研修

  • 2020  Special Affairs  厚生労働省 倫理審査委員会・治験審査委員会委員養成研修

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    厚生労働省 倫理審査委員会・治験審査委員会委員養成研修

  • 2020  Special Affairs  Clinical questionに答える方法としての臨床研究 和白病院臨床研究講演会

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    Clinical questionに答える方法としての臨床研究 和白病院臨床研究講演会

  • 2020  Special Affairs  第85回日本循環器学会学術集会 倫理に関する講演 公正な研究活動とは 〜臨床研究に重点を置いて〜

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    第85回日本循環器学会学術集会 倫理に関する講演
    公正な研究活動とは 〜臨床研究に重点を置いて〜

  • 2020  Special Affairs  医薬品医療機器レギュラトリーサイエンス財団 医療機器エキスパート研修講座 臨床研究法とその課題 〜解決の方向性〜

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    医薬品医療機器レギュラトリーサイエンス財団
    医療機器エキスパート研修講座
    臨床研究法とその課題 〜解決の方向性〜

  • 2020  Special Affairs  PI(Principal Investigator)認定講習

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    PI(Principal Investigator)認定講習

  • 2020  Special Affairs  PI(Principal Investigator)認定講習

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    PI(Principal Investigator)認定講習

  • 2020  Special Affairs  PI(Principal Investigator)認定講習

     詳細を見る

    PI(Principal Investigator)認定講習

  • 2020  Special Affairs  PI(Principal Investigator)認定講習

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    PI(Principal Investigator)認定講習

  • 2020  Special Affairs  臨床研究認定講習

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    臨床研究認定講習

  • 2020  Special Affairs  臨床研究認定講習

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    臨床研究認定講習

  • 2020  Special Affairs  臨床研究認定講習

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    臨床研究認定講習

  • 2020  Special Affairs  臨床研究認定講習

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    臨床研究認定講習

  • 2019  Special Affairs  臨床研究認定講習

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    臨床研究認定講習

  • 2019  Special Affairs  臨床研究認定講習

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    臨床研究認定講習

  • 2019  Special Affairs  臨床研究認定講習

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    臨床研究認定講習

  • 2019  Special Affairs  臨床研究認定講習

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    臨床研究認定講習

  • 2019  Special Affairs  PI(Principal Investigator)認定講習

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    PI(Principal Investigator)認定講習

  • 2019  Special Affairs  PI(Principal Investigator)認定講習

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    PI(Principal Investigator)認定講習

  • 2019  Special Affairs  PI(Principal Investigator)認定講習

     詳細を見る

    PI(Principal Investigator)認定講習

  • 2019  Special Affairs  PI(Principal Investigator)認定講習

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    PI(Principal Investigator)認定講習

  • 2019  Special Affairs  臨床研究を実施するために 和白病院臨床研究講演会

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    臨床研究を実施するために 和白病院臨床研究講演会

  • 2019  Special Affairs  公正な研究活動とは 〜臨床研究に重点を置いて〜 福岡大学コンプライアンス教育講演会

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    公正な研究活動とは 〜臨床研究に重点を置いて〜 福岡大学コンプライアンス教育講演会

  • 2019  Special Affairs  厚生労働省 倫理審査委員会・治験審査委員会委員養成研修

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    厚生労働省 倫理審査委員会・治験審査委員会委員養成研修

  • 2019  Special Affairs  厚生労働省 臨床研究・治験従事者研修

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    厚生労働省 臨床研究・治験従事者研修

  • 2018  Special Affairs  PI(Principal Investigator)認定講習

     詳細を見る

    PI(Principal Investigator)認定講習

  • 2018  Special Affairs  AMED倫理審査委員会・治験審査委員会委員養成研修

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    AMED倫理審査委員会・治験審査委員会委員養成研修

  • 2018  Special Affairs  AMED臨床研究・治験従事者研修

     詳細を見る

    AMED臨床研究・治験従事者研修

  • 2018  Special Affairs  臨床研究認定講習

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    臨床研究認定講習

  • 2018  Special Affairs  臨床研究認定講習

     詳細を見る

    臨床研究認定講習

  • 2018  Special Affairs  臨床研究認定講習

     詳細を見る

    臨床研究認定講習

  • 2018  Special Affairs  PI(Principal Investigator)認定講習

     詳細を見る

    PI(Principal Investigator)認定講習

  • 2017  Special Affairs  PI(Principal Investigator)認定講習

     詳細を見る

    PI(Principal Investigator)認定講習

  • 2017  Special Affairs  臨床研究認定講習

     詳細を見る

    臨床研究認定講習

  • 2017  Special Affairs  PI(Principal Investigator)認定講習

     詳細を見る

    PI(Principal Investigator)認定講習

  • 2017  Special Affairs  臨床研究認定講習

     詳細を見る

    臨床研究認定講習

  • 2017  Special Affairs  PI(Principal Investigator)認定講習

     詳細を見る

    PI(Principal Investigator)認定講習

  • 2017  Special Affairs  臨床研究認定講習

     詳細を見る

    臨床研究認定講習

  • 2017  Special Affairs  AMED臨床研究・治験従事者研修

     詳細を見る

    AMED臨床研究・治験従事者研修

  • 2017  Special Affairs  PI(Principal Investigator)認定講習

     詳細を見る

    PI(Principal Investigator)認定講習

  • 2017  Special Affairs  AMED倫理審査委員会・治験審査委員会委員養成研修

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    AMED倫理審査委員会・治験審査委員会委員養成研修

  • 2016  Special Affairs  PI(Principal Investigator)認定講習

     詳細を見る

    PI(Principal Investigator)認定講習

  • 2016  Special Affairs  臨床研究認定講習

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    臨床研究認定講習

  • 2016  Special Affairs  PI(Principal Investigator)認定講習

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    PI(Principal Investigator)認定講習

  • 2016  Special Affairs  臨床研究認定講習

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    臨床研究認定講習

  • 2016  Special Affairs  臨床研究認定更新講習、司会 演 題:1)「患者申出療養及び関連する各種制度について」        国立がん研究センター中央病院        副病院長 ・企画戦略局長 藤原 康弘先生       2)「国立がん研究センターにおける患者申出療養対応体制」        国立がん研究センター研究支援センター         研究管理部研究管理課長 後澤 乃扶子先生

     詳細を見る

    臨床研究認定更新講習、司会
    演 題:1)「患者申出療養及び関連する各種制度について」
           国立がん研究センター中央病院
           副病院長 ・企画戦略局長 藤原 康弘先生
          2)「国立がん研究センターにおける患者申出療養対応体制」
           国立がん研究センター研究支援センター 
           研究管理部研究管理課長 後澤 乃扶子先生

  • 2016  Special Affairs  PI(Principal Investigator)認定講習

     詳細を見る

    PI(Principal Investigator)認定講習

  • 2016  Special Affairs  臨床研究認定講習

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    臨床研究認定講習

  • 2016  Special Affairs  PI(Principal Investigator)認定講習

     詳細を見る

    PI(Principal Investigator)認定講習

  • 2016  Special Affairs  AMED臨床研究・治験従事者研修

     詳細を見る

    AMED臨床研究・治験従事者研修

  • 2015  Special Affairs  PI(Principal Investigator)認定講習

     詳細を見る

    PI(Principal Investigator)認定講習

  • 2015  Special Affairs  臨床研究認定講習

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    臨床研究認定講習

  • 2015  Special Affairs  PI(Principal Investigator)認定講習

     詳細を見る

    PI(Principal Investigator)認定講習

  • 2015  Special Affairs  PI(Principal Investigator)認定講習

     詳細を見る

    PI(Principal Investigator)認定講習

  • 2015  Special Affairs  PI(Principal Investigator)認定講習

     詳細を見る

    PI(Principal Investigator)認定講習

  • 2015  Special Affairs  臨床研究認定講習

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    臨床研究認定講習

  • 2014  Special Affairs  臨床研究担当看護師育成研修

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    臨床研究担当看護師育成研修

  • 2014  Special Affairs  臨床試験に関するセミナー(リサーチアシスタントセミナー)

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    臨床試験に関するセミナー(リサーチアシスタントセミナー)

  • 2014  Special Affairs  臨床研究認定講習

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    臨床研究認定講習

  • 2014  Special Affairs  臨床試験に関するセミナー(リサーチアシスタントセミナー)

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    臨床試験に関するセミナー(リサーチアシスタントセミナー)

  • 2014  Special Affairs  臨床研究認定講習

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    臨床研究認定講習

  • 2013  Special Affairs  臨床研究担当看護師育成研修

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    臨床研究担当看護師育成研修

  • 2013  Special Affairs  臨床試験に関するセミナー(リサーチアシスタントセミナー)

     詳細を見る

    臨床試験に関するセミナー(リサーチアシスタントセミナー)

  • 2013  Special Affairs  臨床試験に関するセミナー(リサーチアシスタントセミナー)

     詳細を見る

    臨床試験に関するセミナー(リサーチアシスタントセミナー)

  • 2013  Special Affairs  臨床研究認定講習

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    臨床研究認定講習

  • 2013  Special Affairs  臨床研究認定講習

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    臨床研究認定講習

  • 2012  Special Affairs  臨床研究認定講習

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    臨床研究認定講習

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Outline of Social Contribution and International Cooperation activities

  • 医薬品医療機器総合機構 医療機器不具合検討会VAD分科会、厚生労働省「医療ニーズの高い医療機器等の早期導入に関する検討会」WG座長、「医療上の必要性の高い未承認薬・適応外薬検討会議」専門作業班などの座長を務め、新薬・新医療機器の承認審査、市販後安全性評価などに参画、厚生労働省行政に貢献している。日本医療研究開発機構の医療機器開発推進研究事業、循環器疾患・糖尿病等生活習慣病対策実用化研究事業 課題評価委員等を務め、文部科学省、経済産業省行政に協力している。福岡県開発相談コンシェルジュ ふくおか医療福祉関連機器開発・実証コーディネータを務め、地方自治体の行政にも協力している。
    日本循環器学会の倫理委員会委員、レギュラトリーサイエンス学会評議員、臨床薬理学会指導医など学会活動を通じて社会貢献に努めている。

Social Activities

  • 患者さんと考える明日への医療~心臓病をテーマに  医師の立場から・患者の立場から~

    主催;九州大学病院 ARO次世代医療センター 共催;福岡医学会、福岡治験ネットワーク、NPO法人 治験ネットワーク福岡 後援;福岡市、一般社団法人CReS九州、 (公社)福岡県医師会、(一社)福岡市医師会、(一社)福岡県歯科医師会、 (一社)福岡市歯科医師会、(公社)福岡県薬剤師会、(一社)福岡市薬剤師会、 (公社)福岡県看護協会、(社)福岡県臨床衛生検査技師会  アクロス福岡4階 国際会議場  2023.12

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    Audience:General, Scientific, Company, Civic organization, Governmental agency

    Type:Lecture

  • 新薬で救う命、失う命

    九州大学未来創成科学者育成プロジェクト(QFC-SP)  2023.8

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    Audience:Infants, Schoolchildren, Junior students, High school students

    Type:Seminar, workshop

  • 患者さんと考える明日への医療~消化器疾患(むねやけ・つかえ)と小児がんをテーマに 医師の立場から・患者の立場から~

    主催;九州大学病院 ARO次世代医療センター 共催;福岡医学会、福岡治験ネットワーク、NPO法人 治験ネットワーク福岡 後援;福岡市、一般社団法人CReS九州、 (公社)福岡県医師会、(一社)福岡市医師会、(一社)福岡県歯科医師会、 (一社)福岡市歯科医師会、(公社)福岡県薬剤師会、(一社)福岡市薬剤師会、 (公社)福岡県看護協会、(社)福岡県臨床衛生検査技師会  アクロス福岡4階 国際会議場  2022.11

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    Audience:General, Scientific, Company, Civic organization, Governmental agency

    Type:Lecture

  • 理事

    九州臨床研究支援センター  2022.4

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    Audience:General, Scientific, Company, Civic organization, Governmental agency

    Type:Other

  • 取締役(非常勤)

    産学官連携機構九州  2022.4

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    Audience:General, Scientific, Company, Civic organization, Governmental agency

    Type:Other

  • 患者さんと考える明日への医療~がんゲノム医療と白血病の最新治療をテーマに~

    主催;九州大学病院 ARO次世代医療センター 共催;福岡医学会、福岡治験ネットワーク、NPO法人 治験ネットワーク福岡 後援;福岡市、一般社団法人CReS九州、 (公社)福岡県医師会、(一社)福岡市医師会、(一社)福岡県歯科医師会、 (一社)福岡市歯科医師会、(公社)福岡県薬剤師会、(一社)福岡市薬剤師会、 (公社)福岡県看護協会、(社)福岡県臨床衛生検査技師会  アクロス福岡4階 国際会議場  2019.12

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    Audience:General, Scientific, Company, Civic organization, Governmental agency

    Type:Lecture

  • ~患者さんと考える明日への医療~睡眠障害から起こる病気・がん免疫療法をテーマに 医師の立場から・患者の立場から

    主催;九州大学病院 ARO次世代医療センター 共催;福岡医学会、福岡治験ネットワーク、NPO法人 治験ネットワーク福岡 後援;福岡市、一般社団法人CReS九州、 (公社)福岡県医師会、(一社)福岡市医師会、(一社)福岡県歯科医師会、 (一社)福岡市歯科医師会、(公社)福岡県薬剤師会、(一社)福岡市薬剤師会、 (公社)福岡県看護協会、(社)福岡県臨床衛生検査技師会  JR博多シティ 10F 大会議室  2019.2

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    Audience:General, Scientific, Company, Civic organization, Governmental agency

    Type:Lecture

  • ~患者さんと考える明日への医療~睡眠障害から起こる病気・がん免疫療法をテーマに 医師の立場から・患者の立場から

    主催;九州大学病院 ARO次世代医療センター 共催;福岡医学会、福岡治験ネットワーク、NPO法人 治験ネットワーク福岡 後援;福岡市、一般社団法人CReS九州、 (公社)福岡県医師会、(一社)福岡市医師会、(一社)福岡県歯科医師会、 (一社)福岡市歯科医師会、(公社)福岡県薬剤師会、(一社)福岡市薬剤師会、 (公社)福岡県看護協会、(社)福岡県臨床衛生検査技師会  アクロス福岡4階 国際会議場  2017.9

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    Audience:General, Scientific, Company, Civic organization, Governmental agency

    Type:Lecture

  • ~患者さんと考える明日への医療~C型肝炎と大腿骨頭壊死症をテーマに 医師の立場から・患者の立場から

    主催;九州大学病院 ARO次世代医療センター 共催;福岡医学会、福岡治験ネットワーク、NPO法人 治験ネットワーク福岡 後援;福岡市、一般社団法人CReS九州、 (公社)福岡県医師会、(一社)福岡市医師会、(一社)福岡県歯科医師会、 (一社)福岡市歯科医師会、(公社)福岡県薬剤師会、(一社)福岡市薬剤師会、 (公社)福岡県看護協会、(社)福岡県臨床衛生検査技師会  イムズホール  2016.9

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    Audience:General, Scientific, Company, Civic organization, Governmental agency

    Type:Lecture

  • ~患者さんと考える明日への医療~胃がん大腸がんと心の病気・精神の病気について 医師の立場から・患者の立場から

    主催;九州大学病院 ARO次世代医療センター 共催;福岡医学会、福岡治験ネットワーク、NPO法人 治験ネットワーク福岡 後援;福岡市、一般社団法人CReS九州、 (公社)福岡県医師会、(一社)福岡市医師会、(一社)福岡県歯科医師会、 (一社)福岡市歯科医師会、(公社)福岡県薬剤師会、(一社)福岡市薬剤師会、 (公社)福岡県看護協会、(社)福岡県臨床衛生検査技師会  イムズホール  2015.11

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    Audience:General, Scientific, Company, Civic organization, Governmental agency

    Type:Lecture

  • ~患者さんと考える明日への医療~がんをテーマに医師の立場から・患者の立場から

    主催;九州大学病院 ARO次世代医療センター 共催;福岡医学会、福岡治験ネットワーク、NPO法人 治験ネットワーク福岡 後援;福岡市、一般社団法人CReS九州、 (公社)福岡県医師会、(一社)福岡市医師会、(一社)福岡県歯科医師会、 (一社)福岡市歯科医師会、(公社)福岡県薬剤師会、(一社)福岡市薬剤師会、 (公社)福岡県看護協会、(社)福岡県臨床衛生検査技師会  イムズホール  2015.2

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    Audience:General, Scientific, Company, Civic organization, Governmental agency

    Type:Lecture

  • ~患者さんと考える明日への医療~泌尿器と目の病気をテーマに医師の立場から・患者の立場から

    主催;九州大学病院 ARO次世代医療センター 共催;福岡医学会、福岡治験ネットワーク、NPO法人 治験ネットワーク福岡 後援;福岡市、一般社団法人CReS九州、 (公社)福岡県医師会、(一社)福岡市医師会、(一社)福岡県歯科医師会、 (一社)福岡市歯科医師会、(公社)福岡県薬剤師会、(一社)福岡市薬剤師会、 (公社)福岡県看護協会、(社)福岡県臨床衛生検査技師会  イムズホール  2014.2

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    Audience:General, Scientific, Company, Civic organization, Governmental agency

    Type:Lecture

  • 医療機器の開発と規制について 治験ネットワーク福岡中央IRB委員研修

    治験ネットワーク福岡  2013.5

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    Audience:General, Scientific, Company, Civic organization, Governmental agency

    Type:Seminar, workshop

  • ~患者さんと考える明日への医療~膠原病と肺がんの克服に向けて

    主催;九州大学病院 ARO次世代医療センター 共催;福岡医学会、福岡治験ネットワーク、NPO法人 治験ネットワーク福岡 後援;福岡市、一般社団法人CReS九州、 (公社)福岡県医師会、(一社)福岡市医師会、(一社)福岡県歯科医師会、 (一社)福岡市歯科医師会、(公社)福岡県薬剤師会、(一社)福岡市薬剤師会、 (公社)福岡県看護協会、(社)福岡県臨床衛生検査技師会  イムズホール  2013.2

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    Type:Lecture

  • 「なるほど健康アカデミー」第2期 第3回「心臓病の危ないサイン~腕の痛みや昼間の眠気は要注意~」

    読売新聞  よみうりプラザ(読売新聞西部本社1階)福岡市中央区赤坂1-16-5  2011.1

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    Audience:General, Scientific, Company, Civic organization, Governmental agency

    Type:Lecture

    ◆心臓病 サイン見逃すな
     狭心症や心筋梗塞の症状は胸の痛みや圧迫感、絞められるような不快感が多いのですが、脳が痛みの情報を混信させ、下あごや歯、のど、首、腕、上腹部などでも痛みを感じることがあります。全く痛みのない場合もあります。心筋梗塞の女性のうち、43%に胸痛がなかったという報告もあります。このため、女性は男性より精密検査を受ける機会が少なく、結果として心臓病による死亡率も高くなっています。
    ◆睡眠時無呼吸症候群 周囲も注意してあげて
     昼間の眠気は、睡眠時無呼吸症候群(SAS)の症状の一つです。睡眠中に無呼吸が繰り返し起こるため、たびたび脳が目覚めて熟睡できずに起こります。無呼吸の時には血中の酸素が不足し、心筋梗塞や脳卒中など動脈硬化性疾患の危険性を高めるほか、メタボリック症候群の3要素(脂質異常、高血圧、高血糖)のすべてを悪化させます。
     本人は気づかないことが多く、周りの人の注意が必要です。脳波を用いた精密検査を受け、治療法は就寝時に▽マウスピース状の「スリープ・スプリント」を口に入れ、気道を確保する▽空気を加圧して鼻から送り込むCPAP治療(持続陽圧呼吸)などがあります。これらの治療で、心臓発作や脳卒中を予防できることが証明されています。
     日本人の死因では、がんに次いで多いのが心臓病です。発作は歩き始めや寒い時、食後に多発します。異常を感じたら循環器内科を受診してください。

  • 身体障害者福祉法指定医師(心臓機能障害)

    2004

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    身体障害者福祉法指定医師(心臓機能障害)

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Media Coverage

  • 今日感テレビ ほっておくと危ないこの症状、この病気~胸腕わきの痛み・・・密着番組リポーターが体験 30分終了の狭心症オペ~ TV or radio program

    RKB  2009.10

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    今日感テレビ
    ほっておくと危ないこの症状、この病気~胸腕わきの痛み・・・密着番組リポーターが体験 30分終了の狭心症オペ~

Activities contributing to policy formation, academic promotion, etc.

  • 2023.4 - Present   厚生労働省

    「医療上の必要性の高い未承認薬・適応外薬検討会議」構成員

  • 2022.12 - Present   厚生労働省

    「産官学意見交換にかかる検討会」の委員

  • 2022.4 - Present   厚生労働省

    先進医療技術審査部会構成員

  • 2021.5 - 2022.3   厚生労働省

    医療機器基本計画改定案策定タスクフォース

  • 2020.1 - Present   厚生労働省

    患者申出療養に係る検討委員会の委員

  • 2018.12 - Present   厚生労働省

    「非接触式迷走神経刺激による急性冠症候群治療機器の評価指標」を通知として発出、薬生機審発1221第2号、平成30年12月21日

  • 2014.6 - Present   一般社団法人Japan Endovascular Treatment Conference

    Core Lab責任者

  • 2012.4 - 2017.3   厚生労働省 PMDA

    革新的医薬品・医療機器・再生医療製品実用化促進事業
    革新的医療機器の有効性又は安全性評価方法確立のための調査研究

  • 2006.4 - 2020.3   医薬品医療機器総合機構

    医薬品医療機器総合機構 専門委員として新薬、新医療機器等の評価資料吟味、承認審査に対する助言

  • 2003.4 - Present   US FDA, AMDD, PMDA, MHLW(厚労省), JFMDA(医機連)

    Harmonization by Doing

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Travel Abroad

  • 2008.3

    Staying countory name 1:United States   Staying institution name 1:Boston Scientific Corporation

  • 2007.11

    Staying countory name 1:United States   Staying institution name 1:FDA, Center for Devices and Radiological Health

  • 1993.1 - 1997.1

    Staying countory name 1:United States   Staying institution name 1:Division of Circulatory Physiology, College of Physicians and Surgeons, Columbia University

Specialized clinical area

  • Other

    規制科学

  • Biology / Medicine, Dentistry and Pharmacy / Internal Medicine / Cardiology

Clinician qualification

  • Specialist

    The Japanese Circulation Society(JCS)

  • Certifying physician

    The Japanese Society of Internal Medicine(JSIM)

  • FJCS

    The Japanese Circulation Society(JCS)

  • Preceptor

    The Japanese Society of Clinical Pharmacology and Therapeutics

Year of medical license acquisition

  • 1985

Notable Clinical Activities

  • ARO次世代医療センターセンター長として、特定臨床研究が適切かつ円滑に実施されるよう研究体制を整備・支援し、本学の臨床研究全体を推進している。プロトコール評価、作成支援などを実施。倫理的側面や、薬事戦略相談などPMDA、規制当局対応を主に担当。 複数の企業治験(新薬、新医療機器)に薬事・医学専門家として参加。