ICH Releases Draft Guideline E20 on Adaptive Clinical Trial Designs for Public Consultation

On 25 June 2025, the ICH E20 draft guideline titled “Adaptive Design for Clinical Trials” progressed to Step 2b and has now entered the Step 3 public consultation phase. The deadline for comments in the EU is 30 November 2025.

Adaptive designs refer to clinical trial models that incorporate pre-planned modifications based on interim data collected during the study. The E20 guideline focuses on adaptive approaches for confirmatory clinical trials assessing treatment efficacy within the broader drug development framework.

It outlines principles for planning, conducting, analyzing, and interpreting such trials to ensure robust benefit-risk evaluations. The guidance encourages flexibility to accommodate innovative design strategies throughout development.

While it does not prescribe specific statistical techniques, it emphasizes safeguarding trial validity and integrity, particularly in light of adaptations. Proper implementation and evaluation of the adaptations’ impact remain critical.

The draft is accessible via the ICH E20 Expert Working Group webpage.

21-07-2025