Demographic Disparities in Recruitment for Clinical Trials Focused on Endoscopic Bariatric Therapies

Background And Aims: Studies have shown that there are multiple disparities in the recruitment for clinical trials across medical specialties, which makes it challenging to translate research findings to the real world. We performed a systematic review of RCTs focused on EBTs and examined the sex, racial, and ethnic background and age of participants.

Methods: A systematic search of trials pertaining to EBTs was performed. Demographic details from all trials were abstracted and recorded and compared to real-world demographics of obesity in the United States, as reported in the NHANES 2017-March 2020.

Results: A total of 11 trials were included. Mean age of all patients was 43.50 ± 9.25, which differs from the age distribution of obesity in the population (35% between 40 and 59 years). Mean female representation was 89%, which is higher than real-world estimates (50%). A mean of 74% of participants were white, with underrepresentation of African American (21%) and Hispanic (10%) participants as compared to real-world estimates.

Conclusion: Populations affected by obesity are not equitably reflected in clinical trials focused on endoscopic bariatric therapies.