EMA: Draft GL on non-inferiority and equivalence [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2025-11-17 11:05 (218 d 10:30 ago) – Posting: # 24505
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Dear all,

last week the EMA published its

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

End of consultation: 31 May 2026. Once final, it will replace the Guideline on the choice of the non-inferiority margin and the Points to consider on switching between superiority and non-inferiority.

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