Adaptive Designs: Lessons for Inflammatory Bowel Disease Trials.
Fiche publication
Date publication
juillet 2020
Journal
Journal of clinical medicine
Auteurs
Membres identifiés du Cancéropôle Est :
Pr PEYRIN-BIROULET Laurent
Tous les auteurs :
D'Amico F, Danese S, Peyrin-Biroulet L
Lien Pubmed
Résumé
In recent decades, scientific research has considerably evolved in the field of inflammatory bowel diseases (IBD) and clinical studies have become increasingly complex, including new outcomes, different study populations, and additional techniques of re-randomization and centralized control. In this context, randomized clinical trials are the gold standard for new drugs' development. However, traditional study designs are time-consuming, expensive, and only a small percentage of the tested therapies are approved. For this reason, a new study design called "adaptive design" has been introduced, allowing to accumulate data during the study and to make predefined adjustments based on the results of scheduled interim analysis. Our aim is to clarify the advantages and drawbacks of adaptive designs in order to properly interpret study results and to identify their role in upcoming IBD trials.
Mots clés
adaptive designs, inflammatory bowel disease, study design
Référence
J Clin Med. 2020 Jul 23;9(8):