| Project/Area Number |
15K15948
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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 | The University of Tokyo (2017)
Nagoya University (2015-2016) |
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Principal Investigator |
Hirakawa Akihiro 東京大学, 大学院医学系研究科(医学部), 特任准教授 (90609330)
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| Project Period (FY) |
2015-04-01 – 2018-03-31
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| Project Status |
Completed (Fiscal Year 2017)
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| Budget Amount *help |
¥2,860,000 (Direct Cost: ¥2,200,000、Indirect Cost: ¥660,000)
Fiscal Year 2016: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2015: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
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| Keywords | ベイズ流デザイン / 用量探索 / がん臨床試験 / 用量探索デザイン / 第I相試験 / ベイズ統計学 / 用量探索法 / 臨床試験デザイン / 分子標的薬 / ベイズ流アプローチ / がん |
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| Outline of Final Research Achievements |
Molecularly targeted agents (MTAs) modulate specific aberrant pathways in cancer cells while sparing normal tissues, so that some MTAs do not necessarily need to be administered at their recommended dose to have maximal efficacy. Therefore, dose-finding methods that take into account the bivariate-correlating outcomes of both efficacy and toxicity are required for the clinical development of MTAs. In addition, the dose-efficacy model for MTAs is necessary to capture the specific relation between efficacy and the dose level. The efficacy may increase initially with the dose level but then reaches a plateau. We proposed a new dose-finding method using change-point model and also developed phase I/II design for combination of two agents.
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