S1961 Racial and Ethnic Representation in FDA-Supporting Clinical Trials for Inflammatory Bowel Disease From 2000 to 2020: A Persistent Diversity Gap

Introduction: Inflammatory bowel disease (IBD) disproportionately affects diverse racial and ethnic groups in the United States. Over the past 2 decades, the epidemiology of IBD has shown increasing prevalence among non-White populations. However, it is unclear whether pivotal clinical trials supporting United States Food and Drug Administration (FDA) drug approvals reflect this shift. This study aims to systematically evaluate the racial and ethnic representation in major IBD clinical trials from 2000 to 2020. Methods: We reviewed all pivotal phase 3 clinical trials used for FDA approval of IBD therapies between 2000 and 2020. Data were extracted from peer-reviewed publications and FDA drug approval summaries, including race/ethnicity distribution and U.S. site participation. We compared trial demographics to contemporary United States IBD epidemiology derived from peer-reviewed population-based studies. Results: Of 11 major FDA-supporting trials reviewed, only 7 reported race/ethnicity data. Across these trials, White participants comprised a mean of 90% (range: 82–96%) of enrollees. Black, Asian, and Hispanic participants constituted approximately 2–5% each, despite representing a growing proportion of IBD prevalence. The GEMINI 1 trial had the highest non-White inclusion (∼18%), while ACCENT I and ENCORE reported >94% White participants. Several trials, including CLASSIC II, ULTRA 2, UNITI, and OCTAVE, did not report racial breakdowns at all. Comparison with national epidemiologic data (2020 prevalence per 100,000: White 812; Black 504; Asian 403; Hispanic 458) reveals a significant mismatch between disease burden and trial representation. Conclusion: Despite increasing IBD prevalence among minority populations, pivotal trials leading to FDA approval between 2000 and 2020 underrepresent racial and ethnic minorities. These findings highlight an urgent need for inclusive trial designs and regulatory policies to ensure generalizability and equity in IBD therapeutics.