| Project/Area Number |
24700285
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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 | Hyogo Medical University |
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Principal Investigator |
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| Project Period (FY) |
2012-04-01 – 2015-03-31
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| Project Status |
Completed (Fiscal Year 2014)
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| Budget Amount *help |
¥2,860,000 (Direct Cost: ¥2,200,000、Indirect Cost: ¥660,000)
Fiscal Year 2014: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2013: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2012: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
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| Keywords | がん臨床試験 / 用量探索 / 最大耐容量 / 最適用量 / Bayes流接近法 |
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| Outline of Final Research Achievements |
Statistical methodologies for design and analysis of dose or dose-combination finding studies of antitumor agents were developed. First, a comprehensive review of the related designs and topics was provided. Second, a problem that a statistical model for a true relationship between dose or dose combination and toxicity response could be mis-specified, was focused on, and to solve this problem, model-adaptive dose-finding designs were proposed, which allowed us to identify a more reliable or better model during the course of a trial and to support clinical decision making. The simulation study showed that the proposed designs had the advantage of decreasing certain risks, such as those of poor dose allocation and failure to find the optimal dose, which could occur if the statistical model were mis-specified. Finally, several dose-escalation or dose-finding designs for early-phase clinical trials of targeted agents in oncology were investigated with recent topics.
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