A new study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting reveals significant disparities in participation in randomized clinical trials for FDA-approved irritable bowel syndrome (IBS) therapies. The research indicates that these disparities, encompassing racial, ethnic, gender, and geographic factors, may compromise the generalizability of trial results.
Key Findings on Disparities
Anthony Kerbage, MD, from the Cleveland Clinic, and his team assessed demographic, socioeconomic, and educational diversity across 21 trials supporting the FDA approvals of the seven currently available IBS therapies. The analysis included data from 17,428 participants. The study highlighted that while 77.3% of participants were female, ethnicity was disclosed in only 35% of trials, with White participants constituting the majority (79.3%) and Hispanics only 5.9%.
"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 told 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."
Socioeconomic Factors and Trial Access
The study also found that counties without trial sites had smaller average population sizes and lower socioeconomic indicators, including higher poverty rates, lower median household income, reduced educational attainment, and limited broadband internet access. These counties also had higher average Area Deprivation Index scores, indicating greater overall disadvantage.
Addressing Disparities in Future Trials
Kerbage emphasized the importance of using these findings to inform the design of future trials. "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," he stated.
While this research focused on IBS clinical trials, Kerbage expressed interest in expanding this type of analysis to other areas of gastroenterology, particularly other functional disorders.
