Recommendations for Standardizing Clinical Trial Design and Endoscopic Assessment in Postoperative Crohn's Disease.

Date publication

novembre 2021

Journal

Inflammatory bowel diseases

Auteurs

Membres identifiés du Cancéropôle Est :
Pr PEYRIN-BIROULET Laurent

Tous les auteurs :
Hanzel J, Jairath V, De Cruz P, Guizzetti L, Shackelton LM, Bossuyt P, Duijvestein M, Dulai PS, Grossmann J, Hirten RP, Khanna R, Panes J, Peyrin-Biroulet L, Regueiro M, Rubin DT, Singh S, Stidham RW, Sandborn WJ, Feagan BG, D'Haens GR, Ma C

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/34791254

Résumé

The lack of standardized methods for clinical trial design and disease activity assessment has contributed to an absence of approved medical therapies for the prevention of postoperative Crohn's disease (CD). We developed recommendations for regulatory trial design for this indication and for endoscopic assessment of postoperative CD activity.

Mots clés

inflammatory bowel disease, medical therapy, randomized controlled trials, surgery

Référence

Inflamm Bowel Dis. 2021 Nov 13;: