P0973 Accelerating enrollment in phase 2 and 3 Inflammatory Bowel Disease trials through an innovative site network (Oxford University Press)

Recruitment for randomized controlled trials (RCTs) in inflammatory bowel disease (IBD) is challenging, with the average number of patients randomized per site per month declining significantly between 1998 and 2020 from 0.32 to 0.12 in ulcerative colitis (UC) and from 0.65 to 0.08 in Crohn’s disease (CD) (1). Prolonged enrollment increases trial costs and limits availability of new therapies for patients. Trial execution is hindered by substantial operational burdens placed on investigative sites, including study-specific training, administrative tasks (contracting, budget negotiations, regulatory documentation), and inconsistent prescreening workflows. These inefficiencies contribute to delayed site activation, slow patient enrollment, and underperformance across multicenter trials. The objective of this study was to assess site performance data in RCTs for IBD across a site network.