Fiche publication
Date publication
juillet 2025
Journal
Journal of Crohn's & colitis
Auteurs
Membres identifiés du Cancéropôle Est :
Pr PEYRIN-BIROULET Laurent
Tous les auteurs :
Vieujean S, Sands BE, Panaccione R, Rubin DT, Jairath V, Danese S, Peyrin-Biroulet L, Schreiber S, Vermeire S, D'Haens G, Dignass A, Dulai PS, Narula N, Reinisch W
Lien Pubmed
Résumé
The Food and Drug Administration (FDA) and European Medicines Agency (EMA) ensure the safety, efficacy, and security of treatments, including therapies for immune-mediated disorders such as inflammatory bowel disease (IBD). Their clinical trial guidelines aid sponsors in designing robust studies. While the EMA updated its guidelines for ulcerative colitis (UC) in 2018, the FDA issued new recommendations in April 2022. This paper compares these guidelines, assesses their implications for IBD clinical trials, and proposes strategies to improve alignment and trial efficiency.
Mots clés
European Medicines Agency, Food and Drug Administration, ulcerative colitis
Référence
J Crohns Colitis. 2025 07 3;19(7):
