2016 Fiscal Year Final Research Report
Design and statistical analysis in translational clinical trials
| Project/Area Number |
24240042
|
|---|
| Research Category |
Grant-in-Aid for Scientific Research (A)
|
| Allocation Type | Single-year Grants |
|---|
| Section | 一般 |
|---|
| Research Field |
Statistical science
|
|---|
| Research Institution | Nagoya University (2013-2016)
The Institute of Statistical Mathematics (2012) |
|---|
Principal Investigator |
|
|---|
| 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)
|
|---|
| 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)
|
|---|
| Project Period (FY) |
2012-04-01 – 2016-03-31
|
| 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 |
|---|
| 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.
|
| Free Research Field |
統計科学
|
