E20 Adaptive Clinical Trails

E20 EWG Adaptive Clinical Trails

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.

Status: Step 1

Endorsed Documents (Click the links below for complete guidelines)

E20 Concept Paper

E20 Business Plan

E20 Work Plan

*These Guidelines Belongs to ICH website.