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EMA’s New Draft Guideline: Non-Inferiority and Equivalence Comparisons in Clinical Trials
The European Medicines Agency (EMA) has released a major draft guideline " Non-Inferiority and Equivalence Comparisons in Clinical Trials " that updates how non-inferiority and equivalence comparisons should be designed, justified, and analysed in confirmatory clinical trials. This draft replaces two earlier documents: Guideline on the choice of the non-inferiority margin (2005), and Points to consider on switching between superiority and non-inferiority (2000). The new gu
Sharan Murugan
Nov 17, 20252 min read