Analysis of Clinical Trial Screen Failures in Inflammatory Bowel Diseases (IBD): Real World Results from the International Organization for the study of IBD.
Sophie VieujeanJames O LindsayFerdinando D'AmicoVineet AhujaMark S SilverbergAjit SoodJesus K Yamamoto-FurushoMasakazu NagahoriMamoru WatanabeIoannis E KoutroubakisKalliopi FoteinogiannopoulouIrit Avni BironAlissa WalshAn OuttierRie Louise Møller NordestgaardMaria T AbreuMarla DubinskyCorey Allan SiegelEdouard LouisIris DotanWalter ReinischSilvio DaneseDavid T RubinLaurent Peyrin-BirouletPublished in: Journal of Crohn's & colitis (2023)
This first multicenter study analyzing reasons for non-enrollment in IBD RCTs shown that we lose patients at each step. Eligibility criteria, the risk of placebo assignment and insufficient disease activity were part of the main barriers.