Disparities in the burden of gastrointestinal diseases: a comprehensive analysis of data from randomized clinical trials from 2000-2023

Wissam Ghusn; Khushboo Gala; Rudy Mrad; Marita Salame; Serena J. Rahme; Hector Reyes Santiago; Arpan Mohanty; Laura Chiu; Jana G. Hashash; Victor Chedid

Authors Wissam Ghusn, Khushboo Gala, Rudy Mrad, Marita Salame, Serena J. Rahme, Hector Reyes Santiago, Arpan Mohanty, Laura Chiu, Jana G. Hashash, Victor Chedid.

Abstract

Background Gastrointestinal (GI) conditions, such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), metabolic dysfunction-associated steatotic liver disease (MASLD), and gastroesophageal reflux disease (GERD) are major contributors to morbidity and the healthcare burden. Randomized controlled trials (RCTs) are essential for advancing evidence-based medicine, but disparities in participant recruitment often limit the generalizability of trial findings. This study aimed to investigate demographic disparities in GI-related clinical trials, comparing trial populations to real-world data in order to identify gaps in recruitment.

Methods A cross-sectional analysis was conducted using data from United States RCTs from 2000-2023 that focused on major GI conditions: IBD, IBS, MASLD, and GERD. Demographic variables, including age, sex, gender, race and ethnicity, were collected and compared to real-world data from national health surveys. Descriptive statistics summarized the demographic distribution within the trials and highlighted disparities.

Results The analysis revealed significant disparities in recruitment across multiple GI conditions. Despite the growing burden of chronic diseases in older populations, older adults were underrepresented across trials, as a majority of participants were aged between 18 and 65 years. Sex and gender disparities were also observed, with underrepresentation of females in IBD trials and overrepresentation in IBS and MASLD trials, and no representation of gender diverse individuals. White participants were mostly overrepresented, while Black, Asian, and Hispanic individuals were underrepresented in several trials.

Conclusion This study underscores the need for more inclusive recruitment strategies in clinical trials to ensure diverse representation across age, sex, gender, and race.

Keywords Disparities, gastrointestinal, randomized controlled trial, diversity
Ann Gastroenterol 2025; 38 (5): 488-496