Bayesian dose-finding designs for longitudinal toxicity data in molecularly targeted agents

2020 Fiscal Year Final Research Report

• Project/Area Number: 17K00045
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Statistical science
• Research Institution: Tokyo Medical and Dental University (2020); The University of Tokyo (2017-2019)
• Principal Investigator: Hirakawa Akihiro 東京医科歯科大学, 医学部附属病院, 教授 (90609330)
• Project Period (FY): 2017-04-01 – 2021-03-31
• Keywords: 臨床試験デザイン

Outline of Final Research Achievements

We investigated longitudinal toxicity profile of molecularly targeted agents using the data of phase I trials conducted in U.S. National Cancer Institute. Based on the result of this analysis, we developed two dose-finding methods based on the Lasso method and relative dose intensity (RDI) for determining optimal dose of molecularly targeted drugs. Master protocol trials have been emerged in cancer clinical trials in recent times. We also developed a new statistical design for basket trials.

Free Research Field

臨床統計学

Academic Significance and Societal Importance of the Research Achievements

医薬品開発の効率化・迅速化を目的に、革新的臨床試験デザインの研究開発が進んでいる。本研究では、ベイズ統計学を利用した新しい臨床試験デザインを開発した。この成果は、本邦の医薬品開発に資するものであると考える。