ICH E20 Draft Guideline is Available Now on the ICH Website

25 June 2025

The ICH E20 draft Guideline on “Adaptive Design for Clinical Trials” has reached Step 2b of the ICH Process on 25 June 2025 and entered the Step 3 public consultation period. 

The draft Guideline provides guidance on confirmatory clinical trials with an adaptive design intended to evaluate a treatment for a given medical condition within the context of its overall development program. The focus of this guideline is on principles for the planning, conduct, analysis, and interpretation of trials with an adaptive design intended to confirm the efficacy and support the benefit-risk assessment of a treatment.

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"

Pls check the folllow

ICH_E20EWG_Step3_DraftGuideline_2025_0625_0.docx