Diversity, Equity, and Inclusion in Urolithiasis Clinical Trials: Representative Enrollment by Race, Ethnicity, and Sex

Introduction: We sought to assess whether participant enrollment is appropriately representative of the overall urolithiasis population in published urolithiasis clinical trials.

Methods: PubMed was queried for urolithiasis US clinical trials published from 2000 to 2022. Trials were evaluated for reporting patient race/ethnicity and sex data. These were then compared to the stone prevalence reported by the National Health and Nutrition Examination Survey from 2015 to 2018. We calculated a representation quotient (RQ) to describe enrollment of patients and then stratified by geographic location, study type, and funding source.

Results: Of the 180 urolithiasis trials performed in the US, we identified 40 trials (22%) reporting race or ethnicity and 104 trials (58%) reporting sex. Male and female participants are well represented (RQ 0.97 and 1.02, respectively). Overall, the RQ of Black, Asian American and Pacific Islander, White, Hispanic, and mixed/other participants is 1.84, 1.06, 1.04, 0.46, and 0.34, respectively. Trials completed in the Western Section and multi-institutional trials have the most proportional enrollment, while trials in the South Central and Southeastern Sections have underrepresentation of mixed/other and Hispanic patients. Enrollment was similar among all trial subtypes. Government- and industry-funded trials had more diverse enrollment than academic-funded trials.

Conclusions: Only 1 in 4 published US urolithiasis trials report race or ethnicity enrollment. Mixed race and Hispanic participants are consistently underrepresented, while Black participants are overrepresented. Government- and industry-sponsored multi-institutional trials have the most proportional representation. Investigators should prioritize inclusive recruitment and improve reporting practices to accurately reflect the diversity of the urolithiasis population.