| Project/Area Number |
21830031
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| Research Category |
Grant-in-Aid for Research Activity Start-up
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| Allocation Type | Single-year Grants |
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| Research Field |
Sociology
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| Research Institution | The University of Tokyo |
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Principal Investigator |
TASHIRO Shimon The University of Tokyo, 大学院・医学系研究科, 特任助教 (50548550)
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| Project Period (FY) |
2009 – 2010
|
| Project Status |
Completed (Fiscal Year 2010)
|
| Budget Amount *help |
¥2,366,000 (Direct Cost: ¥1,820,000、Indirect Cost: ¥546,000)
Fiscal Year 2010: ¥1,248,000 (Direct Cost: ¥960,000、Indirect Cost: ¥288,000)
Fiscal Year 2009: ¥1,118,000 (Direct Cost: ¥860,000、Indirect Cost: ¥258,000)
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| Keywords | 医薬品規制 / 医療社会学 / 精神医学 / 臨床試験 / 抗うつ薬 / プラセボ / 患者参加 / 規制の虜 |
|---|
| Research Abstract |
In this study, I focus on a controversial case in Japan about a randomized withdrawal trial of antidepressant, and analyze ethical and social issues underlying it. In conclusion, I suggest that there are three major issues to be considered (1) ethical issues in study design, (2) regulation of clinical trials in Japan, and (3) patient participation in clinical trials at the planning phase.
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