Use of Bayesian methods in clinical development - Scientific guideline

The purpose of the proposed guideline is to address key considerations for studies that utilise Bayesian statistics in clinical development.

Keywords: Bayesian statistics, clinical trials, medicine development

Current version

Concept paper for the development of a reflection paper on the use of Bayesian methods in clinical development

Draft: consultation closed Consultation dates: 30/01/2026 to 30/04/2026 Reference Number: EMA/CHMP/1813/2026 Summary:

The purpose of the proposed guideline is to address key considerations for studies that utilise Bayesian statistics in clinical development.

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