Phase 1, 2 and 3 trials in inflammatory bowel diseases: a practical guide for the non-specialist.
Fiche publication
Date publication
janvier 2020
Journal
Journal of Crohn's & colitis
Auteurs
Membres identifiés du Cancéropôle Est :
Pr PEYRIN-BIROULET Laurent
Tous les auteurs :
D'Amico F, Baumann C, Rousseau H, Danese S, Peyrin-Biroulet L
Lien Pubmed
Résumé
In the last decades several new molecules have been developed in the field of inflammatory bowel diseases. However, the process that leads to the approval and use of a new drug is very long, expensive, and complex, consisting of various phases. There is a pre-clinical phase that is performed on animals and a clinical phase that is instead directed to humans. Each research phase aims to evaluate different aspects of the drug and involves a specific target group of subjects. In addition, many aspects must be considered in the evaluation of a clinical trial: randomization, presence of a control group, blind design, type of performed data analysis, and patient stratification. The objective of this review is to provide an overview of the clinical trial phases of a new drug in order to better understand and interpret their results.
Mots clés
clinical trial phases, inflammatory bowel disease, randomized clinical trial
Référence
J Crohns Colitis. 2020 Jan 4;: