ICH E20 adaptive designs for clinical trials - Scientific guideline

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.

Keywords: clinical trial design, adaptive design, interim analysis

Current effective version

ICH E20 guideline on adaptive designs for clinical trials - Step 2b

Draft: consultation closed Consultation dates: 30/06/2025 to 30/11/2025 Reference Number: EMA/CHMP/ICH/206586/2025 Summary:

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.

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Related content

• ICH guidelines: Clinical trials

External links

• Efficacy guidelines