Disparities in IBS Clinical Trial Participation Suggest Healthcare Research Inequities

Findings from a recent study are calling attention to significant racial, ethnic, gender, and geographic disparities in participation in randomized clinical trials for FDA-approved irritable bowel syndrome (IBS) therapies, potentially compromising the generalizability of trial results.

The research was presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting in Philadelphia, Pennsylvania, by Anthony Kerbage, MD, an internal medicine resident at the Cleveland Clinic. Study results indicated an overrepresentation of female and African American patients, a notable lack of reporting on ethnicity, and worse socioeconomic indicators in counties without access to clinical trial sites.

“IBS does not affect different groups in the same way. For example, we know it's more common in women, so I wouldn't be interested in a trial that only looks at men with IBS,” Kerbage explained to HCPLive. “These trials are very important because they are leading to the approval of these medications, so if I'm going to rely on trial results to say this medication works well and is safe, I want to know that it was tested on all different groups of people because this is what I'm going to see in the clinic."

To assess demographic, socioeconomic, and educational diversity in IBS drug trials, Kerbage and colleagues looked at demographic and trial site location data from 21 trials used to support the FDA approvals of the 7 currently available IBS therapies. The analysis encompassed 17,428 participants, the majority of whom were female (77.3%) with a mean age of 45.4 years.

Although race was reported in 95% of the trials, investigators noted only 35% disclosed ethnicity. White participants constituted the majority at 79.3%, while Hispanics accounted for 5.9%.

Investigators also pointed out counties without trial sites had smaller average population sizes compared to trial and trial-adjacent counties. Socioeconomic indicators such as poverty rates, median household income, educational attainment, and broadband internet access were lower in counties without trial sites, which had higher average Area Deprivation Index scores.

“The first step is identifying the problem, and this is what we did. We now know that there are disparities, but the second step is taking this information into consideration during the design stage of future trials,” Kerbage said.

Although his research focused specifically on diversity in IBS clinical trials, Kerbage expressed interest in seeing this kind of work conducted “in all areas of GI,” especially other functional disorders.

Editors’ note: Kerbage has no relevant disclosures.

Reference

^{Kerbage A, Loesch J, Hamza E, et al. P4043 - Evaluating Equity in Clinical Trial Accessibility: A Systematic Review of Demographic, Socioeconomic, and Educational Disparities in IBS Drug Trials. Paper presented at: ACG 2024 Annual Scientific Meeting. Philadelphia, Pennsylvania. October 25-30, 2024.}