Development of statistical design for small clinical trials
| Project/Area Number |
26330037
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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 | Kyoto Prefectural University of Medicine |
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Principal Investigator |
Teramukai Satoshi 京都府立医科大学, 医学(系)研究科(研究院), 教授 (20359798)
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| Co-Investigator(Renkei-kenkyūsha) |
DAIMON Takashi 兵庫医科大学, 医学部, 教授 (40372156)
YOSHIMURA Kenichi 金沢大学附属病院, 特任教授 (30415517)
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| Project Period (FY) |
2014-04-01 – 2018-03-31
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| Project Status |
Completed (Fiscal Year 2017)
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| Budget Amount *help |
¥3,770,000 (Direct Cost: ¥2,900,000、Indirect Cost: ¥870,000)
Fiscal Year 2016: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2015: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2014: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
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| Keywords | 臨床試験デザイン / ベイズ流統計学 / 適応的デザイン / 標本サイズ設定 / 中間モニタリング / 標本サイズ再設定 |
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| Outline of Final Research Achievements |
(1) We proposed an extension of a Bayesian adaptive design denoted by the PSSD (predictive sample size selection design), to monitor efficacy, adapt the sample size during the trial and add continuous monitoring safety (Teramukai S, et al. Statistics in Medicine, 2015;34:3029-3039). (2) I published a textbook for introducing the Bayesian clinical trial design (Teramukai S. Naze Bayes-wo tsukawanainoka? Kinpodo, 2017). (3) We reviewed the basket trial design and proposed the new Bayesian design using the similarity measure among posterior distributions (Teramukai S, et al. Japan Society of Clinical Trials and Research, the 9th Annual Meeting, 2018). (4) We applied the PSSD to the phase II clinical trials for high risk rhabdomyosarcoma patients, sponsored by JCCG (Japan Children’s Cancer Group).
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Report
(5 results)
Research Products
(14 results)
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[Journal Article] A multicenter phase II study of salvage photodynamic therapy using talaporfin sodium (ME2906) and a diode laser (PNL6405EPG) for local failure after chemoradiotherapy or radiotherapy for esophageal cancer2017
Author(s)
Yano T, Kasai H, Horimatsu T, Yoshimura K, Teramukai S, Morita S, Tada H, Yamamoto Y, Kataoka H, Kakushima N, Ishihara R, Isomoto H, Muto M.
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Journal Title
Oncotarget
Volume: 8
Pages: 22135-22144
DOI
NAID
Related Report
Peer Reviewed / Open Access
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[Journal Article] Effects of zoledronic acid and the association between its efficacy and gamma delta T cells in postmenopausal women with breast cancer treated with preoperative hormonal therapy: a study protocol.2014
Author(s)
Sumi E, Sugie T, Yoshimura K, Tada H, Ikeda T, Suzuki E, Tanaka Y, Teramukai S, Shimizu A, Toi M, Minato N
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Journal Title
J. Transl. Med.
Volume: 12
Pages: 310-310
DOI
Related Report
Peer Reviewed / Open Access
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