Statistical Issues in Complex Medical Product Development
| Project/Area Number |
23500348
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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) |
SUGIMOTO Tomoyuki 弘前大学, 大学院・理工学研究科, 准教授 (70324829)
UESAKA Hiroyuki 大阪大学, 学内共同利用施設, 研究員 (60446250)
HAYASHI Kenichi 大阪大学, 大学院・医学系研究科, 助教 (70617274)
SUGITANI Toshifumi 大阪大学, 大学院・医学系研究科, 助教 (70626879)
SOZU Takashi 京都大学, 大学院・医学研究科, 准教授 (80408723)
山本 紘司 大阪大学, 医学部附属病院, 講師 (10548176)
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| Project Period (FY) |
2011 – 2013
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| Project Status |
Completed (Fiscal Year 2013)
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| Budget Amount *help |
¥5,070,000 (Direct Cost: ¥3,900,000、Indirect Cost: ¥1,170,000)
Fiscal Year 2013: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2012: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2011: ¥2,210,000 (Direct Cost: ¥1,700,000、Indirect Cost: ¥510,000)
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| Keywords | 生物統計学 / 臨床試験 / 個別化医療 / 医薬品開発 / 国際共同臨床試験 / 多重エンドポイント / エンリッチメントデザイン / 国際研究者交流 / 部分集団解析 / Enrichmentデザイン / 国際共同試験 |
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| Research Abstract |
The major objective of the research was on the challenging issues and recent methodological developments that may be applicable in the rapid growing area of research on innovative clinical trials design and analysis including adaptive designs, enrichment designs, analysis for multiple objectives. We provides efficient strategies for designing the clinical trials with multiple co-primary endpoints within group-sequential designs. In addition, we discuss adaptive enrichment method in confirmatory clinical trials, using method combing the partition testing and graphical approach. we also identify common practical issues in multi-regional clinical trials via case studies.
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Report
(4 results)
Research Products
(65 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)
Pages: 28972913-28972913
DOI
Related Report
Peer Reviewed / Open Access / Acknowledgement Compliant
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