The following is a summary of “Analysis of Clinical Trial Screen Failures in Inflammatory Bowel Diseases [IBD]: Real World Results from the International Organization for the study of IBD,” published in the April 2024 issue of Gastroenterology by Vieujean et al.
Enrollment rates for clinical trials using RCTs to test new inflammatory bowel disease (IBD) treatments have significantly declined.
Researchers conducted a retrospective study identifying barriers preventing patients with IBD from participating in sponsored, multi-center phase IIb-III RCTs.
They invited all members of IOIBD (n = 58) to participate. Barriers to participation were categorized into why patients with active IBD weren’t suitable for RCTs, why eligible patients declined participation, and reasons for screen failure (SF) in consenting patients. Assessed in a 4-week study, which included symptomatic patients needing treatment change, a retrospective 6-month survey further scrutinized SF reasons.
The results showed 106 patients (60 male [56.6%], 63 Crohn’s disease [CD] [59.4%]) across 10 centers globally; 65 were not proposed for an RCT (primarily due to eligibility criteria). Among the 41 offered an RCT, eight declined (primarily due to reluctance to receive a placebo), and 28 agreed to participate, with five failing screening and 23 eventually included. In SFs, 107 patients (61 male [57%], 67 CD [62.6%]) from 13 centers worldwide participated, with insufficient disease activity being the main reason.
Investigators concluded that an initial, multi-center analysis of barriers to enrollment in IBD RCTs revealed ongoing patient loss throughout the process. Key hurdles included eligibility criteria, potential placebo assignment, and inadequate disease activity.
Source: academic.oup.com/ecco-jcc/article-abstract/18/4/548/7326696
