| Project/Area Number |
22700290
|
|---|
| Research Category |
Grant-in-Aid for Young Scientists (B)
|
| Allocation Type | Single-year Grants |
|---|
| Research Field |
Statistical science
|
|---|
| Research Institution | Kyoto University |
|---|
Principal Investigator |
SOZU Takashi 京都大学, 医学研究科, 准教授 (80408723)
|
|---|
| Project Period (FY) |
2010 – 2011
|
| Project Status |
Completed (Fiscal Year 2011)
|
| Budget Amount *help |
¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2011: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2010: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
|
|---|
| Keywords | 医薬品開発 / 臨床試験 / 標本サイズ / 生物統計学 / 多重性 / 優越性 / 非劣性 / 症例数設計 |
|---|
| Research Abstract |
Statistical methodologies for design and analysis of clinical trials with multiple co-primary endpoints were developed, where the study objective of the trials is to demonstrate statistical significance for all of the endpoints.(1) Power and sample size determinations for each scale of endpoint were provided. The derived convenient sample size formula for continuous normally distributed endpoints provided a clear relationship between the required sample size and the correlations among the endpoints.(2) A further investigation was necessary to improve the testing method combining superiority and non-inferiority of a new treatment compared to a control treatment.(3) The required sample sizes of two methods to alleviate conservative approach of testing co-primary endpoints were practically comparable in typical clinical trial settings.
|
