Differences Between the 2016 and 2022 Food and Drug Administration Guidance-Implications for Design and Interpretation of Clinical Trials in Ulcerative Colitis.

Fiche publication

Date publication

avril 2024

Journal

Crohn's & colitis 360

Auteurs

Membres identifiés du Cancéropôle Est :
Pr PEYRIN-BIROULET Laurent

Tous les auteurs :
Hanzel J, Ma C, Peyrin-Biroulet L, Danese S, Sands BE, Jairath V

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/38948490

Résumé

In 2022, the Food and Drug Administration (FDA) updated its draft guidance for drug development in ulcerative colitis, replacing the version from 2016. Several changes from the 2016 version merit further discussion as they impact clinical trial design and the interpretation of trial results.