A mixed approach for proving non-inferiority in clinical trials with binary endpoints

Détails

ID Serval
serval:BIB_57153ABBA5E3
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
A mixed approach for proving non-inferiority in clinical trials with binary endpoints
Périodique
Biometrical journal
Auteur(s)
Rousson Valentin, Seifert Burkhardt
ISSN
1521-4036[electronic]
Statut éditorial
Publié
Date de publication
2008
Peer-reviewed
Oui
Volume
50
Numéro
2
Pages
190-204
Langue
anglais
Résumé
When a new treatment is compared to an established one in a randomized clinical trial, it is standard practice to statistically test for non-inferiority rather than for superiority. When the endpoint is binary, one usually compares two treatments using either an odds-ratio or a difference of proportions. In this paper, we propose a mixed approach which uses both concepts. One first defines the non-inferiority margin using an odds-ratio and one ultimately proves non-inferiority statistically using a difference of proportions. The mixed approach is shown to be more powerful than the conventional odds-ratio approach when the efficacy of the established treatment is known (with good precision) and high (e.g. with more than 56% of success). The gain of power achieved may lead in turn to a substantial reduction in the sample size needed to prove non-inferiority. The mixed approach can be generalized to ordinal endpoints.
Mots-clé
Anti-Bacterial Agents/therapeutic use, Clindamycin/therapeutic use, Data Interpretation, Statistical, Endpoint Determination, Female, Humans, Odds Ratio, Randomized Controlled Trials as Topic/methods, Sample Size, Therapeutic Equivalency, Vaginosis, Bacterial/drug therapy
Pubmed
Web of science
Création de la notice
27/02/2009 16:35
Dernière modification de la notice
20/08/2019 15:11
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