[Non-inferiority and equivalence trials: Key methodological issues].

This article presents the key points of the methodology of non-inferiority and equivalence trials in order to inform the readers of such trials about the issues and critical points. The general methodology (hypotheses, decision rules, number of subjects required, and strategy of analysis) is presented using examples and graphic illustrations. The issues and critical points are identified and discussed, in particular the choice of the comparator and of the margin of non-inferiority.
PMID: 28693836 [PubMed - as supplied by publisher]

Source: Revue de Medecine Interne - July 13, 2017 Category: Internal Medicine Tags: Rev Med Interne Source Type: research