Analysis of Clinical Trial Screen Failures in Inflammatory Bowel Diseases [IBD]: Real World Results from the International Organization for the study of IBD

Sophie Vieujean, James O. Lindsay, Ferdinando D’Amico, Vineet Ahuja, Mark S. Silverberg, Ajit Sood, Jesus K. Yamamoto-Furusho, Masakazu Nagahori, Mamoru Watanabe, Ioannis E. Koutroubakis, Kalliopi Foteinogiannopoulou, Irit Avni Biron, Alissa Walsh, An Outtier, Rie Louise Møller Nordestgaard, Maria T. Abreu, Marla Dubinsky, Corey Siegel, Edouard Louis, Iris DotanWalter Reinisch, Silvio Danese, David T. Rubin, Laurent Peyrin-Biroulet

Research output: Contribution to journalArticlepeer-review

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Abstract

Background: Recruitment for randomized controlled trials [RCTs] in inflammatory bowel diseases [IBD] has substantially dropped over time. This study aimed to assess reasons why IBD patients are not included in sponsored multicentre phase IIb–III RCTs. Methods: All IOIBD members [n = 58] were invited to participate. We divided barriers to participation as follows: [1] reasons patients with active IBD were not deemed appropriate for an RCT; [2] reasons qualified patients did not wish to participate; and [3] reasons for screen failure [SF] in patients agreeing to participate. We assess these in a 4-week prospective study including, consecutively, all patients with symptomatic disease for whom a treatment change was required. In addition, we performed a 6-month retrospective study to further evaluate reasons for SF. Results: A total of 106 patients (60 male [56.6%], 63 Crohn’s disease [CD] [59.4%]), from ten centres across the world, were included in the prospective study. An RCT has not been proposed to 65 of them [mainly due to eligibility criteria]. Of the 41 patients to whom an RCT was offered, eight refused [mainly due to reluctance to receive placebo] and 28 agreed to participate. Among these 28 patients, five failed their screening and 23 were finally included in an RCT. A total of 107 patients (61 male [57%], 67 CD [62.6%]), from 13 centres worldwide, were included in our retrospective study of SFs. The main reason was insufficient disease activity. Conclusion: This first multicentre study analysing reasons for non-enrolment in IBD RCTs shows that we lose patients at each step. Eligibility criteria, the risk of placebo assignment, and insufficient disease activity were part of the main barriers.

Original languageEnglish
Pages (from-to)548-559
Number of pages12
JournalJournal of Crohn's and Colitis
Volume18
Issue number4
DOIs
StatePublished - 1 Apr 2024

Keywords

  • Inflammatory bowel disease
  • non-enrolment
  • randomized controlled trials
  • screen failure

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