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EMA – Public consultation: Draft guideline on non-inferiority and equivalence comparisons in clinical trials

This document provides guidance on the planning, conduct, analysis and interpretation of non-inferiority and equivalence comparisons in clinical trials. It replaces the ‘Guideline on the choice of the non-inferiority margin’ (EMEA/CPMP/EWP/2158/99) and ‘Points to consider on switching between superiority and non-inferiority’ (CPMP/EWP/482/99).

The Draft guideline on non-inferiority and equivalence comparisons in clinical trials can be found on the dedicated page on the EMA Website.

The deadline for comments is 31 May 2026. Templates and other open consultations can be found on the EMA Website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (11 décembre 2025). EMA – Public consultation: Draft guideline on non-inferiority and equivalence comparisons in clinical trials. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/15bv5


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