| Project/Area Number |
15K00058
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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 | Hyogo Medical University |
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Principal Investigator |
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| Project Period (FY) |
2015-04-01 – 2019-03-31
|
| Project Status |
Completed (Fiscal Year 2018)
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| Budget Amount *help |
¥3,770,000 (Direct Cost: ¥2,900,000、Indirect Cost: ¥870,000)
Fiscal Year 2017: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2016: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2015: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
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| Keywords | がん臨床試験 / 用量探索 / スケジュール探索 |
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| Outline of Final Research Achievements |
Literatures on the existing designs and related topics for finding and determining the optimal dose and/or schedule were investigated. Consequently, it was found that model-assisted designs have gained much attention.
The meta-analytic approach and power prior approach for the use of histrical information were compared through a simulation study. Consequently, the best approach might be chosen based on the operating characteristics of each approach.
The novel sample size determination methods, which utilize the posterior probabilities calculated from predefined efficacy and inefficacy criteria for binary endpoints, were proposed. The proposed methods could allow for the declaration of worthwhileness or unpromisingness of one treatment compared as another treatment, with a high probability when the true efficacy probability of the former group is higher or lower, respectively, than that of the latter group.
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| Academic Significance and Societal Importance of the Research Achievements |
本研究成果により，抗がん剤の用量探索研究におけるデータ獲得のためのデザインをはじめ，そのデータに対するモデルの構築，推測，評価等を統計科学に立脚した形式でより強固なものにすることができた．結果として，抗がん剤治療を成功に導くための最適な用量及び投与スケジュールの探索と決定がより精確なものになり，がん患者さんをより良い用量及び投与スケジュールで治療する機会を提供することに寄与できた．
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