This topic was endorsed by the ICH Assembly in June 2018.
The E20 EWG is working on the development of a new E20 Guideline on “Adaptive Clinical Trials” on the design, conduct, analysis, and interpretation of adaptive clinical trials that provides a transparent and harmonized set of principles for the regulatory review of these studies in a global drug development program. These principles should also provide the flexibility to evaluate / discuss innovative approaches to clinical trial design throughout the development process.
Following MC approval in June 2025 the E20 Guideline title was changed to “Adaptive Designs for Clinical Trials“.
