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Research on ethics of early/exploratory clinical trials

Research Project

Project/Area Number 25460621
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Medical sociology
Research InstitutionOsaka University

Principal Investigator

Yamamoto Yoichi  大阪大学, 医学部附属病院, 准教授 (20335342)

Project Period (FY) 2013-04-01 – 2016-03-31
Project Status Completed (Fiscal Year 2015)
Budget Amount *help
¥2,470,000 (Direct Cost: ¥1,900,000、Indirect Cost: ¥570,000)
Fiscal Year 2015: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2014: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2013: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Keywords研究倫理 / 国際情報交換 / 臨床試験 / 早期探索的臨床試験 / 被験者保護 / 倫理審査委員会 / 健康人ボランティア / 医学哲学
Outline of Final Research Achievements

We all enjoy the benefits of medical drugs. However, the results of my survey show that half of the general public has not thought over the fact that healthy volunteers participate in clinical trials. Some, although a minority, show ethical concerns about the implementation of first in man clinical trials and the process of approval. Most healthy volunteers think that they are participating in first in man clinical trials for remuneration, but some participate for the medical contribution and for helping patients. Cancer patients and their family think that cancer patients participate in first in man clinical trials for their treatment, and to help future patients. The results indicate that altruism may be shown in first in man clinical trials. Now, innovation of the development of new drugs is one of the national policies. We are asked to reconsider these issues presented here in realistic medical research fronts.

Report

(4 results)
  • 2015 Annual Research Report   Final Research Report ( PDF )
  • 2014 Research-status Report
  • 2013 Research-status Report
  • Research Products

    (5 results)

All 2015 Other

All Presentation (4 results) (of which Int'l Joint Research: 2 results) Remarks (1 results)

  • [Presentation] 新薬開発のfirst in man試験~現代社会におけるボランティアのポジショニングに関する考察~2015

    • Author(s)
      山本洋一
    • Organizer
      第27回日本生命倫理学会年次大会
    • Place of Presentation
      千葉大学いのはなキャンパス(千葉県・千葉市)
    • Year and Date
      2015-11-28
    • Related Report
      2015 Annual Research Report
  • [Presentation] Enrolling Healthy Volunteers in Phase I Clinical Trials2015

    • Author(s)
      Yoichi Yamamoto
    • Organizer
      Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP)
    • Place of Presentation
      Nagasaki University (Nagasaki prefecture・Nagasaki city)
    • Year and Date
      2015-11-23
    • Related Report
      2015 Annual Research Report
    • Int'l Joint Research
  • [Presentation] 新薬開発:恩恵を受けるものの責任を考える2015

    • Author(s)
      山本洋一
    • Organizer
      第34回日本医学哲学・倫理学会大会
    • Place of Presentation
      新潟大学(新潟県・新潟市)
    • Year and Date
      2015-11-07
    • Related Report
      2015 Annual Research Report
  • [Presentation] Considerations on the responsibility of people who receive benefits from medical drugs UNESCO Conference2015

    • Author(s)
      Yoichi Yamamoto
    • Organizer
      BIOETHICS, MEDICAL ETHICS & HEALTH LAW
    • Place of Presentation
      Royal Continental Hotel Naples (Italy)
    • Year and Date
      2015-10-20
    • Related Report
      2015 Annual Research Report
    • Int'l Joint Research
  • [Remarks] 大阪大学医学部附属病院未来医療開発部未来医療センター

    • URL

      http://www.med.osaka-u.ac.jp/pub/hp-crc/

    • Related Report
      2015 Annual Research Report

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Published: 2014-07-25   Modified: 2019-07-29  

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