Statistical frameworks for efficient decision-making in complex clinical trial designs
| Project/Area Number |
26330038
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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 | Osaka University |
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Principal Investigator |
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| Co-Investigator(Kenkyū-buntansha) |
杉本 知之 鹿児島大学, 理工学研究科, 教授 (70324829)
寒水 孝司 東京理科大学, 工学部, 准教授 (80408723)
高橋 佳苗 国立研究開発法人国立循環器病研究センター, 研究開発基盤センター, 研究員(任期付) (80726761)
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| Project Period (FY) |
2014-04-01 – 2017-03-31
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| Project Status |
Completed (Fiscal Year 2016)
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| Budget Amount *help |
¥4,810,000 (Direct Cost: ¥3,700,000、Indirect Cost: ¥1,110,000)
Fiscal Year 2016: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
Fiscal Year 2015: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2014: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
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| Keywords | 臨床試験 / 多重性 / 群逐次デザイン / 適応的デザイン / 多重エンドポイント / 統計科学 / 生存時間データ / 標本サイズ再計算 / 医薬品開発 / 予測バイオマーカ / エンリッチメントデザイン |
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| Outline of Final Research Achievements |
Many recent clinical trials for evaluating efficacy and safety of new interventions include multiple objectives, especially in medical product development. There are advantages of clinical trials with multiple objectives over trials with a single objective saving time and resources and more completely characterizing the intervention effects. However, such clinical trials require conducting a number of statistical tests and analyses associated with multiple objectives, and then, complex multiplicity or multiple testing problems occur. In this project, our team has conducted research on the design and analysis of such clinical trials, especially focusing on group-sequential and adaptive designs for clinical trials with multiple objectives, including design modification during trials
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Report
(4 results)
Research Products
(54 results)
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[Journal Article] Sample size determination in group-sequential clinical trials with two co-primary endpoints2014
Author(s)
Asakura, K., Hamasaki, T., Sugimoto, T., Hayashi, K., Evans, S., Sozu T
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Journal Title
Statistics in Medicine
Volume: (First published online)
Issue: 17
Pages: 2897-2913
DOI
Related Report
Peer Reviewed / Open Access
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