Racial, Ethnic, and Socioeconomic Disparities in Celiac Disease Trials: A Systematic Review of Participant Diversity and Trial Site Distribution.

Abstract

Celiac disease (CeD) has traditionally been regarded as a condition affecting non-Hispanic Whites although 10% of cases occur in under-represented minorities. There is growing demand for randomized clinical trials (RCTs) investigating CeD treatments; however, minority participation in CeD trials has not been examined. The aim of this study was to investigate demographic and socioeconomic diversity in RCTs for treatments of CeD. We conducted a systematic review of RCTs investigating treatments for CeD in the United States. We included studies on serology or biopsy-confirmed CeD conducted domestically. First, participant demographics were analyzed. Second, trial sites were mapped, and county-level demographic and socioeconomic characteristics were compared. We identified 10 RCTs (2011-2023) with 319 participants (mean age: 40.9 years); 70.2% were women. Race was reported in 9 of 10 trials, with 99.6% White and no Black, Asian, or Native American participants. Ethnicity was reported in 4 of 10 trials, with 8.6% Hispanic. Counties without trial sites were more rural, had smaller populations, higher poverty rates, lower incomes, lower educational attainment, and higher Area Deprivation Index scores, indicating greater socioeconomic deprivation. Despite efforts to improve minority inclusion in RCTs, significant disparities persist in CeD trials, with minimal racial and ethnic diversity. As demand for pharmacologic treatments grows, future trials must address these gaps through diverse recruitment, equitable site distribution, and targeted outreach to ensure emerging therapies are generalizable and accessible to all patients.