Skip to Main content Skip to Navigation
Journal articles

Essais de non-infériorité et d’équivalence : points clés de méthodologie

Abstract : Non-inferiority and equivalence trials aim to promote new treatments that are not expected to be superior to existing ones in a given indication. In order to compensate for a possible loss of efficacy, the new treatment should offer other advantages compared to the reference treatment, a better safety of use for example. Their methods somewhat differ from those of superiority trials, often better known to the medical community. 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.
Document type :
Journal articles
Complete list of metadatas

Cited literature [29 references]  Display  Hide  Download

https://www.hal.inserm.fr/inserm-01576223
Contributor : Beatrice Faraldo <>
Submitted on : Tuesday, August 22, 2017 - 3:51:32 PM
Last modification on : Monday, May 11, 2020 - 3:04:02 PM

File

Herr_PMID 28693836.pdf
Files produced by the author(s)

Identifiers

Collections

Citation

Marie Herr, Alexis Descatha, Philippe Aegerter. Essais de non-infériorité et d’équivalence : points clés de méthodologie. La Revue De Médecine Interne, Elsevier, 2017, Epub ahead of print. ⟨10.1016/j.revmed.2017.06.010⟩. ⟨inserm-01576223⟩

Share

Metrics

Record views

438

Files downloads

5090