Non-inferiority and equivalence comparisons in clinical trials - Scientific guideline

HumanScientific guidelines

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This guidance is superseded by guideline on non-inferiority and equivalence comparisons in clinical trials.

Document history

Guideline on the choice of the non-inferiority margin

Adopted Reference Number: EMEA/CPMP/EWP/2158/99 Legal effective date:

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Draft guideline on non-inferiority and equivalence comparisons in clinical trials

Draft: consultation closed Consultation dates: to Reference Number: EMA/301654/2025 Summary:

This guideline 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).

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

English (EN) (498.78 KB - PDF)

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