Recommendations for Broadening Eligibility Criteria in Inflammatory Bowel Disease Clinical Trials

Background: Clinical trial recruitment for patients with inflammatory bowel disease [IBD] has become more challenging over time. We aimed to develop recommendations for broadening IBD clinical trial eligibility, to improve the inclusion of a more representative patient population in a more efficient timeline. Methods: We applied the RAND/UCLA Appropriateness Method, focused on broadening IBD clinical trial eligibility. A literature review was performed for seven domains, each representing a different area related to trial recruitment. Based on these domains, 32 statements were developed. A questionnaire was sent to IBD specialists so as to anonymously vote on each statement with regards to its appropriateness and feasibility. After the first round of voting, participants met for a moderated discussion to review all statements. At the end of the discussion, a second round of anonymous voting led to the final recommendations. Results: The final round of voting resulted in 26 statements. All were rated as feasible and 25 of 26 rated as appropriate. Recommendations generally are to be more inclusive of complicated disease phenotypes, more liberal around safety criteria, to recognise the importance of non-invasive imaging and biomarkers, to minimise the washout period and to not enforce a minimum or maximum number of prior medications, to allow a recently recorded colonoscopy to count as a baseline study, and to be less restrictive of age. Conclusion: Recommendations to broaden clinical trial eligibility were found to be both appropriate and feasible, with a high degree of agreement amongst an international group of IBD specialists.