ICH E20 Adaptive Clinical Trails Guidelines

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.

ICH E20 Adaptive Clinical Trails Guidelines: