| Project/Area Number |
16200022
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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 | Seikei University |
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Principal Investigator |
IWASAKI Manabu Seikei University, Faculty of Science and Technology, Professor, 理工学部, 教授 (40255948)
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| Co-Investigator(Kenkyū-buntansha) |
OHTAKI Megu Hiroshima University, Research Institute for Radiation Biology and Medicine, Professor, 原爆放射線医科学研究所, 教授 (20110463)
ORIGASA Hideki University of Toyama Graduate School, Biostatistics and Clinical Epidemiology, Professor, 大学院・医学薬学研究部, 教授 (20245038)
HAMADA Chikuma Tokyo University of Science, Faculty of Engineering, Associate Professor, 工学部, 助教授 (50324611)
MATSUYAMA Yutaka University of Tokyo School of Medicine, Biostatistics, Associate Professor, 大学院・医学系研究科, 助教授 (20282618)
FUJITA Toshiharu Seikei University, Institute of Statistical Mathematics, Department of Data Science, Professor, データ科学研究系, 教授 (30175575)
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| Project Period (FY) |
2004 – 2006
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| Project Status |
Completed (Fiscal Year 2006)
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| Budget Amount *help |
¥44,980,000 (Direct Cost: ¥34,600,000、Indirect Cost: ¥10,380,000)
Fiscal Year 2006: ¥14,300,000 (Direct Cost: ¥11,000,000、Indirect Cost: ¥3,300,000)
Fiscal Year 2005: ¥14,300,000 (Direct Cost: ¥11,000,000、Indirect Cost: ¥3,300,000)
Fiscal Year 2004: ¥16,380,000 (Direct Cost: ¥12,600,000、Indirect Cost: ¥3,780,000)
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| Keywords | Efficacy and Safety of Drugs / Biostatistics / Medical Statistics / Clinical Trials / Post-Marketing Surveillance / Data Analysis / Data Mining / 臨床試験の統計解析 / 医薬品の市販後安全性情報 / 観察研究における因果推論 / 生活の質(QOL)の分析 / 不完全データの統計分析 / 自発報告データベース / シグナル検出 |
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| Research Abstract |
This research started in 2004 to develop new methodologies in assessing efficacy and safety of drugs. The research group consists of seven members: M. Iwasaki, head investigator, and six other investigators. The members are all young and middle-aged biostatisticians and epidemiologists. They are active researchers in this field, and published nine books and 86 research articles within three years of research period (2004-2006 academic years). The articles were published in international and local journals, and are listed in REFERENCES section of this report. Books are all written in Japanese and published from Japanese publishers as are shown in REFERENCES section. The research group was invited by the editor of the Journal of Japan Statistical Society to contribute research articles, and seven articles were published in an issue of the journal.
During these three years, the research group organized 13 symposiums and seminars in total, and also had 13 research meetings in Tokyo. We invited four distinguished scholars from the USA and France, and had opportunities to communicate each other. The research group joined the Network of Excellence (NOE) of the Risk Analysis Research Center of the Institute of Mathematical Statistics, Tokyo.
As is shown in numerous published works, the activity of our group covered various fields concerning efficacy and safety of drugs. They include design strategy of clinical trials, meta-analysis of several trials, genomic analysis, and so on. One notable achievement is the development of methodology of signal detection from database of adverse reactions of drugs. A signal detection system is now developing by the Pharmaceuticals and Medical Device Agency (PMDA) with assistance of some of our research group members.
All the research activities are shown in our WEB page (www.kakenbio.com), which got approximately 15,000 accesses during these three years.
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