Drug Evaluation Committee Japanese Translation of FDA Guidance on Adaptive Design
Data Science Subcommittee
August 2021
There has been active research and discussion on the use of adaptive design in clinical trials, and there are many examples of its use. Adaptive clinical trials (clinical trials using adaptive design) have been adopted as a topic for ICH-E20, and the ICH-E20 Expert Working Group is discussing the topic with the aim of developing a unified guideline.
While adaptive design has potential advantages such as limiting patient exposure to unsafe or ineffective treatments, saving trial resources, and accelerating the development process, there are several considerations that must be taken into account in order to properly conduct a series of clinical trial procedures, including study design selection, study conduct, and statistical analysis. However, there are some issues to be considered in order to properly conduct a series of clinical trial procedures such as study design selection, study conduct, and statistical analysis. However, due to the absence of domestic guidelines on adaptive design and the fact that the FDA's guidance is up-to-date and comprehensive, the Drug Evaluation Committee's Data Science Subcommittee FY2021 Continuing Task Force2 has decided to adopt the November 2019 release of the adaptive design We have prepared a Japanese translation of the FDA guidance, Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry. We hope this translation will help you understand and use adaptive design appropriately.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Data Science Subcommittee FY2021 Ongoing Task Force 2
Japanese translation of FDA Guidance on Adaptive Design (584KB)