2013 Fiscal Year Final Research Report
Study on reseach design and statistical inferences for exploratory clinical researches
| Project/Area Number |
23500349
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Statistical science
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| Research Institution | Osaka University |
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Principal Investigator |
UESAKA Hiroyuki 大阪大学, 臨床医工学融合研究教育センター, 招聘教授 (60446250)
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| Co-Investigator(Renkei-kenkyūsha) |
KADA Akiko 独立行政法人国立病院機構, 名古屋医療センター臨床研究センター, 室長 (70399608)
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| Research Collaborator |
MORIKAWA Toshihiko 元久留米大学, バイオ統計センター
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| Project Period (FY) |
2011 – 2013
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| Keywords | 臨床試験デザイン / sample size reestimation / adaptive design / multiple comparison / gatekeeping procedure |
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| Research Abstract |
We developed two-phase and three-stage designs for a situation where information on sample size estimation was very scarce. In these designs sample size is re-estimated after the first phase. The second phase consists of two stages and one interim analysis is performed. Sample size is not re-estimated at this phase. Theses designs were proved to give about 85 to 95 percent of the power of the single stage design and much less average sample sizes than that design.
We also investigated multiple testing problems. When we wish to test a family of several elementary hypotheses which are structured according to the importance and logical relationships among them. We obtained explicit formulae of adjusted p-values of each test of hypothesis. Furthermore, we defined multiple parallel/fixed sequence hypothesis structure, which consists of several ordered treatments and equally important multiple endpoints. We also developed explicit formulae for the adjusted p-values of elementary hypotheses.
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