Heterogeneity in Definitions of Endpoints for Clinical Trials of Ulcerative Colitis: A Systematic Review for Development of a Core Outcome Set.

Fiche publication

Date publication

mai 2018

Journal

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

Auteurs

Membres identifiés du Cancéropôle Est :
Pr PEYRIN-BIROULET Laurent

Tous les auteurs :
Ma C, Panaccione R, Fedorak RN, Parker CE, Nguyen TM, Khanna R, Siegel CA, Peyrin-Biroulet L, D'Haens G, Sandborn WJ, Feagan BG, Jairath V

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/28843356

Résumé

Advances in development of therapeutic agents for ulcerative colitis (UC) have been paralleled by innovations in trial design. It would be useful to identify a core outcome set, to standardize outcome definitions for efficacy and safety in clinical trials. We performed a systematic review of efficacy and safety outcomes reported in placebo-controlled randomized controlled trials of patients with UC.