| Project/Area Number |
21700303
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| Research Category |
Grant-in-Aid for Young Scientists (B)
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| Allocation Type | Single-year Grants |
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| Research Field |
Statistical science
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| Research Institution | Kyoto University |
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Principal Investigator |
OBA koji Kyoto University, 北海道大学病院, 助教 (30422926)
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| Project Period (FY) |
2009 – 2010
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| Project Status |
Completed (Fiscal Year 2010)
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| Budget Amount *help |
¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2010: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2009: ¥520,000 (Direct Cost: ¥400,000、Indirect Cost: ¥120,000)
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| Keywords | 医薬生物 / ゲノム統計解析 / 医薬生物・ゲノム統計解析 / 臨床試験 / 直接効果 |
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| Research Abstract |
The aim of this study was to propose the new method for evaluation of validity of a surrogate variable using the information of causal direct effect called Natural Direct Effect. In addition, we applied this proposed method to the large scale randomized controlled trial, CASE-J trial, and evaluated the surrogacy of blood pressure on the cardiovascular events.
From the statistical point of view, it is meaningful that this study could extend the method of statistical validation for the surrogate endpoint to the case that a surrogate is a continuous and a true variable is repeated measurement. The results showed that the proposed method could evaluate the average natural direct and indirect effects through the achieved systolic blood pressure in the randomized controlled trial and a natural indirect effect through the systolic blood pressure reduction of about 2 mmHg was large for the cerebrovascular events out of cardiovascular events.
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