Bayesian study designs for new drug development in early-stage cancer clinical trials.

2014 Fiscal Year Final Research Report

• Project/Area Number: 24500345
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Statistical science
• Research Institution: Kyoto University (2013-2014); Yokohama City University (2012)
• Principal Investigator: MORITA Satoshi 京都大学, 医学(系)研究科(研究院), 教授 (60362480)
• Co-Investigator(Kenkyū-buntansha): DAIMON Takashi 兵庫医科大学, 教授 (40372156) ; TERAMUKAI Satoshi 京都府立医科大学, 教授 (20359798) ; TOI Masakazu 京都大学, 大学院医学研究科, 教授 (10207516)
• Research Collaborator: THALL Peter F. University of Texas M.D. Anderson Cancer Center, 教授
• Project Period (FY): 2012-04-01 – 2015-03-31
• Keywords: バイオマーカー / 個別化医療 / ベイズ流統計学 / 臨床腫瘍学

Outline of Final Research Achievements

We have developed novel study designs for phase I and phase II clinical trials aiming to boost new drug developments. We have proposed a new statistical approach to appropriately combine historical data into a current phase I clinical trial in which the safety of a new study treatment is evaluated. In addition, we have proposed to integrate biomarker data to design a phase II clinical trial to efficiently develop a stratified therapy. We will use our proposed methods in actual clinical trials.

Free Research Field

生物統計