EMA – Publication of the overview of comments on ICH E20 guideline on adaptive designs for clinical trials
Following a public consultation carried out from 30 June 2025 to 30 November 2025, the EMA recently published the overview of comments on the ICH E20 guideline on adaptive designs for clinical trials.
This document provides guidance on confirmatory clinical trials planned with an adaptive design within the context of its overall development programme, allowing pre-specified modifications of the trial design based on an interim analysis of the on-going trial.
In addition, the guideline discusses opportunities for the application of Bayesian methodology. Input is sought whether there are further examples where Bayesian methodology can be employed in a way that it can be discussed within the clinical context of use.
More information on the dedicated page on the EMA Website.
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vroby (28 mars 2026). EMA – Publication of the overview of comments on ICH E20 guideline on adaptive designs for clinical trials. ELSIBI. Consulté le 7 octobre 2026 à l’adresse https://doi.org/10.58079/15ysn
