A Systematic Review and Meta-analysis Evaluating Diversity in Crohn's Disease Clinical Trials

Research output: Contribution to conferencePosterpeer-review

Abstract

Purpose: Crohn's Disease (CD) is an autoimmune disease of the digestive system affecting approximately 3 million Americans. CD has bimodal occurrence, peaking between ages 20-40 and 50-60, and is more common in whites, with increasing rates in Asian and Hispanix/Latinx populations.

Previous research has called for increased inclusion of diverse participants in inflammatory bowel disease studies, but less is known about the current state of CD-specific trials. This study aimed to evaluate the inclusion rates of participants across sex, race, ethnicity, and age groups in Crohn's Disease Clinical trials performed in the United States.

Design Methods: We conducted a systematic review and meta-analysis, searching MEDLINE (PubMed) and Embase (Elsevier) for randomized and non-randomized clinical trials investigating CD interventions. Search results were uploaded to Rayyan. Authors screened records in a masked, duplicate manner. Studies eligible for our systematic review met the following inclusion criteria: (1) published on or after January 1, 2018 through December 31, 2023, (2) assessed the efficacy of an intervention on enro11ed participants with CD, and 3) were conducted in the United States.

Results: 13 trials met our inclusion criteria and were analyzed for sex, race, ethnicity, and age of study participants. Regarding sex, 5 trials (38.5%) received a diversity rating of Good, 4 trials (30.8%) received a rating of Fair, and 4 trials (30.8%) were rated as Poor. Race/ethnicity was most frequently rated as Poor representation, with 12 trials (92.3%) meeting this criterion. Only one trial (7.7%) received a race/ethnicity diversity rating of Good.

Conclusion: CD Clinical Trials in the United States consistently underrepresent Black, Asian, and Hispanic populations while simultaneously overrepresenting females. Future trials should recruit historically excluded populations for better representation and evidence for clinical trial outcomes. Recruiting more diverse populations would increase evidence of safety and efficacy for new Crohn's interventions in the United States.
Original languageAmerican English
Pages11
StatePublished - 13 Sep 2024
Event2024 Symposium on Tribal and Rural Innovations in Disparities and Equity for Health - Oklahoma State University College of Osteopathic Medicine at the Cherokee Nation, Tahlequah, United States
Duration: 13 Sep 202413 Sep 2024

Conference

Conference2024 Symposium on Tribal and Rural Innovations in Disparities and Equity for Health
Abbreviated titleSTRIDE 2024
Country/TerritoryUnited States
CityTahlequah
Period13/09/2413/09/24

Fingerprint

Dive into the research topics of 'A Systematic Review and Meta-analysis Evaluating Diversity in Crohn's Disease Clinical Trials'. Together they form a unique fingerprint.

Cite this