J Clin Med. 2020 Jul 23;9(8):E2350. doi: 10.3390/jcm9082350.

Ferdinando D'Amico ^1 2, Silvio Danese ^1 3, Laurent Peyrin-Biroulet ²

Author information

• ¹Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20090 Milan, Italy.
• ²Department of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, 54500 Vandoeuvre-lès-Nancy, France.
• ³Department of Gastroenterology, Humanitas Clinical and Research Center-IRCCS, Rozzano, 20089 Milan, Italy.

Abstract

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.