Evaluating Equity in Clinical Trial Accessibility: An Analysis of Demographic, Socioeconomic, and Educational Disparities in Irritable Bowel Syndrome Drug Trials

Abstract

Background/Aim: Irritable Bowel Syndrome (IBS), a disorder of gut-brain interaction imposes a significant economic burden due to its high prevalence and the chronic nature of its symptoms. IBS currently has seven FDA-approved treatments. Despite efforts to improve diversity in randomized controlled trials (RCT) participation, significant disparities remain in various medical fields, yet these have not been thoroughly examined within the context of IBS. We aimed to investigate the demographic, socioeconomic, educational and geographic disparities in IBS drug trials. Methods: We conducted a systematic review on Phase III RCTs on FDA-approved drugs for the treatment of IBS with constipation (IBS-C) and IBS with diarrhea (IBS-D) in the United States. Data on participant demographics and trial site locations were extracted and analyzed to identify disparities. Results: Our analysis included 17 studies encompassing 21 trials with 17,428 participants. 77.3% of participants were female, with a mean age of 45.4 years. Race was reported in 95% of the trials, but only 35% disclosed ethnicity. White participants constituted the majority at 79.3%. Hispanics accounted for only 5.9%. 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, with higher average Area Deprivation Index scores indicating greater deprivation. Conclusion: The findings highlight significant disparities in IBS trial participation across race, ethnicity, gender, and socioeconomic backgrounds. This raises potential concerns about generalizability of trial outcomes and underscores the need for strategies to enhance inclusivity in clinical research.