P5408 - Racial and Ethnic Representation in FDA-Supporting Clinical Trials for Inflammatory Bowel Disease From 2000 to 2020: A Persistent Diversity Gap

Karolina Kaczmarczyk, MD, MPH¹, Idan Grossmann, MD², Vera Hapshy, DO³, Harshavardhan Sanekommu, MD⁴, Lee Peng, MD, PhD⁴
1Hackensack Meridian Jersey Shore University Medical Center, Neptune, NJ; 2Hackensack Meridian Health, Bradley Beach, NJ; 3Hackensack Meridian JSUMC, Neptune City, NJ; 4Hackensack Meridian Health, Neptune, NJ

Introduction: Inflammatory bowel disease (IBD) disproportionately affects diverse racial and ethnic groups in the United States. Over the past two decades, the epidemiology of IBD has shown increasing prevalence among non-White populations. However, it is unclear whether pivotal clinical trials supporting 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 U.S. 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.

Discussion: 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.


Figure: Figure 1. Racial Composition in Major IBD Trials Supporting FDA Approval (2000 - 2020)

Disclosures:
Karolina Kaczmarczyk indicated no relevant financial relationships.
Idan Grossmann indicated no relevant financial relationships.
Vera Hapshy indicated no relevant financial relationships.
Harshavardhan Sanekommu indicated no relevant financial relationships.
Lee Peng indicated no relevant financial relationships.

Karolina Kaczmarczyk, MD, MPH¹, Idan Grossmann, MD², Vera Hapshy, DO³, Harshavardhan Sanekommu, MD⁴, Lee Peng, MD, PhD⁴. P5408 - Racial and Ethnic Representation in FDA-Supporting Clinical Trials for Inflammatory Bowel Disease From 2000 to 2020: A Persistent Diversity Gap, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.