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Swissmedic: Launch of public consultation on ICH Guideline E20 “Adaptive Designs for Clinical Trials”

8 July 2025

Swissmedic: Launch of public consultation on ICH Guideline E20 “Adaptive Designs for Clinical Trials”

Swissmedic has launched the public consultation on Guideline E20 “Adaptive Designs for Clinical Trials” of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Comments can be issued until 30 November 2025 by stakeholders.

The document provides a guideline on confirmatory clinical trials planned with an adaptive design within the context of its overall development program. Currently, the lack of harmonised guidelines on adaptive clinical trials is hindering the use of innovative designs in global drug development programs. Therefore, the new ICH guideline addresses issues such as the common terminology for adaptive clinical trials, the principles for the design, conduct, analysis, and proper interpretation of adaptive clinical trials, including considerations of the risk of erroneous conclusions, and the documentation important for the planning and implementation of adaptive clinical trials and the interactions between sponsors and regulatory agencies.

For more information, see here.

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