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