| Project/Area Number |
25730015
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| Research Category |
Grant-in-Aid for Young Scientists (B)
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| Allocation Type | Multi-year Fund |
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| Research Field |
Statistical science
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| Research Institution | Nagoya University |
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Principal Investigator |
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| Project Period (FY) |
2013-04-01 – 2015-03-31
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| Project Status |
Completed (Fiscal Year 2014)
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| Budget Amount *help |
¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000)
Fiscal Year 2014: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2013: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
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| Keywords | 生物統計学 / ベイズ統計学 / 臨床試験論 / 用量探索法 / がん / 用量探索 / 第I相試験 / がん臨床試験 / 第Ｉ相試験 / 併用療法 / ベイズ統計 / 縮小推定 |
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| Outline of Final Research Achievements |
We developed a novel dose-finding method for two-agent combination phase I trials on the basis of the shrunken predictive probability of toxicity. In this method, a shrinkage logistic regression model that allows distinct shrinkage multipliers for the coefficients of the main effects of two agents and their interaction on the probability of toxicity constructs the toxicity outcome. We also proposed dose-escalation/de-escalation decision rules on the basis of the shrunken predictive probability of toxicity. Simulation studies under various patterns of monotonic dose-response relationships for combinations of two agents demonstrated that the proposed method performed no worse than the existing two dose-finding methods we selected. The proposed dose-finding method improved the recommendation rates for the true MTD combinations and suppressed those for the unacceptable dose combinations compared with the existing methods.
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