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Public consultation on ICH Guideline E20 “Adaptive Designs for Clinical Trials” launched in Switzerland

08.07.2025

Swissmedic launches the public consultation on Guideline E20 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), with a deadline of 30 November 2025 for comments

Stakeholders in Switzerland have until 30 November 2025 to comment on the draft of Guideline E20 “Adaptive Designs for Clinical Trials”.

There is an increasing interest in using adaptive clinical trials in modern drug development. However, the lack of harmonised guideline on adaptive clinical trials hinders the use of these innovative designs in global drug development programs in instances where they may be able to provide added value to drug development while maintaining the evidence for regulatory decision making.

This new ICH guideline will address and provide clarity on:

  • A common terminology for adaptive clinical trials;
  • The potential benefits of adaptive clinical trials and areas (e.g., study settings and design features) of meaningful applications;
  • The principles for the design, conduct, analysis, and proper interpretation of adaptive clinical trials, including considerations of the risk of erroneous conclusions (e.g., control of false positive and false negative conclusions, and reliability of effect estimates), maintenance of trial integrity, and handling of operational challenges;
  • The documentation that is important for the planning and implementation of adaptive clinical trials and the interactions between sponsors and regulatory agencies.

Comments can be provided to networking@swissmedic.ch using the feedback form specified by ICH. Stakeholders will receive confirmation of receipt of their comments, but no feedback on the individual comments. After completion of the public consultation phase, the comments submitted will be discussed in the responsible ICH working groups and taken into account where appropriate.

Links to the guideline and feedback form can be found on the following page:

International Council for Harmonisation (ICH)

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