P0973 Accelerating enrollment in phase 2 and 3 Inflammatory Bowel Disease trials through an innovative site network

Abstract Background 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. Methods We included data collected from Phase 2 and 3 RCTs in IBD supported by the network beginning April 2024 through October 2025. Studies were included only if the network had been formally engaged before the trial’s official start date. Participating sites were integrated into a global gastroenterology clinical trial network that provides standardized start-up processes, study-specific training, operational support, and technology-enabled tools to enhance patient identification and enrollment efficiency. Randomization rates (patients per site per month) were calculated for each study and summarized using the overall weighted average and median. Additional site performance metrics included time from site selection to activation, time from activation to first patient screened, and time from activation to first patient randomized. Results Six RCTs were included (three UC, three CD), including two phase 2 and four phase 3 studies. Network support covered a total of 27 unique sites (21 United States (U.S.), 6 Europe (EU)). The network demonstrated a weighted average randomization rate of 0.34 overall and 0.26 at U.S. sites, with consistent performance across phases and indications. Overall randomization rates were 3.4-fold higher than 2020 published benchmarks of 0.10 (1). Median times from site selection to activation, activation to first patient screened, and activation to first patient randomized were 74, 45, and 83 days, respectively - faster than industry benchmarks (site selection to activation: 122 - 171 days (2-4); activation to first patient randomized: 140 days (4)). Conclusion This site network represents a scalable solution to the longstanding recruitment crisis in IBD RCTs. This model represents an operational and cultural shift in trial execution and could meaningfully accelerate the development of novel therapies for patients. References: 1. Uzzan M, Bouhnik Y, Abreu M, et al., Declining Enrolment and Other Challenges in IBD Clinical Trials: Causes and Potential Solutions, Journal of Crohn’s and Colitis, 2023 July; 17(7):1066-1078. 2. Pioneering platform trials in IBD – case study. PSI CRO. Retrieved from https://psi-cro.com/phase-2-first-platform-trials-ibd-case-study/ 3. Goyal A, Schibler T, Alhanti B, et al., Assessment of North American Clinical Research Site Performance During the Start-up of Large Cardiovascular Clinical Trials, JAMA Network Open, 2021 Jul; 4(7). 4. Demaerschalk B, Brown R, Roubin G, et al., Factors Associated with Time to Site Activation, Randomization, and Enrollment Performance in a Stroke Prevention Trial, Stroke, 2017 Aug; 48(9):2511-2518. Conflict of interest: Peyrin-Biroulet, Laurent: CONSULTING Abbvie, Abivax, Adacyte, Alimentiv, Alfasigma, Amgen, Apini, Banook, BMS, Celltrion, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Iterative Health, Janssen, Lilly, LifeMine, Medac, Morphic, MSD, Nordic Pharma, Novartis, Oncodesign Precision Medicine, ONO Pharma, OSE Immunotherapeuthics, Par’ Immune, Pfizer, Prometheus, Roche, Roivant, Samsung, Sandoz, Sanofi, Sorriso, Spyre, Takeda, Teva, ThirtyfiveBio, Tillots, Vectivbio, Vedanta, Ventyx. LECTURE Abbvie, Alfasigma, Amgen, Biogen, Celltrion, Ferring, Galapagos, Genentech, Gilead, Iterative Health, Janssen, Lilly, Medac, MSD, Nordic Pharma, Pfizer, Sandoz, Takeda, Tillots Chapman, J. Casey: J.C.C. reports having served as a consultant of AbbVie, Medtronic Advisory Board of AbbVie, Pfizer, Takeda Speaker Bureau for AbbVie, Bristol Myers Squib, Janssen, Pfizer, Takeda. Younes, Ziad: Ziad Younes has received research support from Gilead, Intercept, BMS, Madrigal, Cymabay, BMS, Axcella, HighTide, NST, NovoNordisk, Novartis, and Zydus has served as a consultant or on advisory boards for Gilead and Intercept and has served as a speaker for Gilead, Intercept, and AbbVie. DuVall, George A.: GD reports potential conflicts of interest with Iterative Health. Kierkuś, Jarosław: Grant: Nestle Other: Nutricia, Abbvie, Nestle Soghigian, Haig: HS is an employee of Iterative Health and may hold stock or stock options in Iterative Health. Feuchtbaum, Dana: DF is an employee of Iterative Health and may hold stock or stock options in Iterative Health. Molenda, Mark: MM is an employee of Iterative Health and may hold stock or stock options in Iterative Health.