Drug Evaluation Committee Japanese Translation of FDA Guidance on Adaptive Design
August 2021
There has been active research and discussion regarding clinical trials that employ adaptive designs, and numerous examples of their application have been observed.Furthermore, adaptive clinical trials (clinical trials employing adaptive designs) have been adopted as a topic under ICH-E20, and discussions are underway within the ICH-E20 Expert Working Group with the aim of developing harmonized guidelines.
While adaptive designs offer potential benefits—such as limiting patient exposure to treatments that are unsafe or unlikely to be sufficiently effective, conserving trial resources, and accelerating the development process—there are several considerations to ensure that the entire clinical trial process, including trial design selection, trial conduct, and statistical analysis, is carried out appropriately.However, given the absence of domestic guidelines on adaptive designs,and the fact that the FDA guidance is the most up-to-date and comprehensive available, the Data Science Subcommittee of the Drug Evaluation Committee’s FY2021 Continuing Task Force 2 has prepared a Japanese translation of the FDA guidance on adaptive designs, “Adaptive Design Clinical Trials for Drugs and Biologics: Guidance for Industry,” which was published in November 2019.We hope this translation will contribute to a better understanding and appropriate use of adaptive design.
Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee,
, Data Science Subcommittee, FY2021 Continuing Task Force 2
Japanese Translation of the FDA Guidance on Adaptive Design (584KB)