Open consultation

Consultation on the International Council for Harmonisation Guideline E20 for adaptive clinical trial design

• From: Medicines and Healthcare products Regulatory Agency
• Published: 24 July 2025

Summary

The MHRA is consulting with UK stakeholders to gather feedback and comments on ICH E20, a new international guideline.

This consultation closes at
11:59pm on 30 November 2025

Consultation description

The MHRA is consulting with UK stakeholders to gather feedback and comments on a new international guideline on the design, conduct, analysis, and interpretation of adaptive clinical trials that provides a transparent and harmonised set of principles for the regulatory review of these studies in a global drug development program.

Documents

ICH E20 Public Consultation

HTML

Ways to respond

Email to:

ichconsultations@mhra.gov.uk

Published 24 July 2025