Development of statistical design for small clinical trials

2017 Fiscal Year Final Research Report

• Project/Area Number: 26330037
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Statistical science
• Research Institution: Kyoto Prefectural University of Medicine
• Principal Investigator: Teramukai Satoshi 京都府立医科大学, 医学(系)研究科(研究院), 教授 (20359798)
• 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)
• Project Period (FY): 2014-04-01 – 2018-03-31
• 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

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).

Free Research Field

生物統計学