ICH E20 Draft Guideline on Adaptive Design for Clinical Trials

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 EU deadline for comments is 30 November 2025.

Background

An adaptive design is a clinical trial (CT) design that allows for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial.

The ICH 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 the guideline is on principles for the planning, conduct, analysis, and interpretation of trials to confirm the efficacy and support the benefit-risk assessment of a treatment. These principles should also provide the flexibility to evaluate / discuss innovative approaches to CT design throughout the development process.

However, the guideline does not discuss the use of specific statistical methods. The impact of trial adaptations on the statistical validity of trial results and maintenance of trial integrity also relies on appropriate execution of the trial and careful assessment of the potential impact of envisaged adaptations on trial conduct.

The E20 draft Guideline is available for download on the E20 EWG page.