| Project/Area Number |
24240042
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| Research Category |
Grant-in-Aid for Scientific Research (A)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
Statistical science
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| Research Institution | Nagoya University (2013-2016)
The Institute of Statistical Mathematics (2012) |
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Principal Investigator |
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| Co-Investigator(Kenkyū-buntansha) |
江口 真透 統計数理研究所, 数理・推論研究系, 教授 (10168776)
手良向 聡 京都府立医科大学, 医学(系)研究科(研究院), 教授 (20359798)
松浦 正明 帝京大学, 公衆衛生学研究科, 教授 (40173794)
森田 智視 京都大学, 医学(系)研究科(研究院), 教授 (60362480)
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| Co-Investigator(Renkei-kenkyūsha) |
YAMAGUCHI Takuhiro 東北大学, 大学院医学系研究科, 教授 (50313101)
FUJISAWA Hironori 統計数理研究所, 数理・推論研究系, 教授 (00301177)
DAIMON Takashi 兵庫医科大学, 医学部, 教授 (40372156)
SOZU Takashi 東京理科大学, 工学部, 准教授 (80408723)
KAWAGUCHI Atsushi 佐賀大学, 大学院医学系研究科, 教授 (60389319)
ITO Yoichi 北海道大学, 大学院医学研究科, 准教授 (80061167)
YAMANAKA Takeharu 横浜市立大学, 大学院医学研究科, 教授 (00325466)
HIRAKAWA Akihiro 東京大学, 大学院医学系研究科, 准教授 (90609330)
NOMA Hisashi 統計数理研究所, データ科学研究系, 准教授 (70633486)
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| Project Period (FY) |
2012-04-01 – 2016-03-31
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| Project Status |
Completed (Fiscal Year 2016)
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| Budget Amount *help |
¥27,560,000 (Direct Cost: ¥21,200,000、Indirect Cost: ¥6,360,000)
Fiscal Year 2015: ¥7,280,000 (Direct Cost: ¥5,600,000、Indirect Cost: ¥1,680,000)
Fiscal Year 2014: ¥5,590,000 (Direct Cost: ¥4,300,000、Indirect Cost: ¥1,290,000)
Fiscal Year 2013: ¥7,670,000 (Direct Cost: ¥5,900,000、Indirect Cost: ¥1,770,000)
Fiscal Year 2012: ¥7,020,000 (Direct Cost: ¥5,400,000、Indirect Cost: ¥1,620,000)
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| Keywords | 臨床試験 / 統計的デザイン / データ解析 / 個別化医療 / 先端医療技術 / 臨床試験の計画と解析 / 先端医療技術の開発 / 診断法開発 / ゲノムデータの解析 / ゲノムデータ解析 / 統計解析 / バイオマーカー / 予測解析 |
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| Outline of Final Research Achievements |
We conducted researches on the design and statistical analysis of clinical trials for developing advanced medical technologies, including those of regeneration medicine and personalized medicine. Specifically, we developed novel statistical methods for 1) the analysis of prognostic and predictive markers using omics data, 2) the design and analysis of earlier exploratory clinical trials (exploration of dose-response relationship and patient subgroups), and 3) the design and analysis of confirmative clinical trials (test and unbiased estimation of treatment effects). In particular, research outcomes related to the clinical development of personalized medicine were published as a monograph, which is one of the first attempts to provide a systematic coverage of all stages of clinical trials for the development of personalized medicine.
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