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Racial and Ethnic Diversity in Clinical Studies Reported to ClinicalTrials.gov, 2009-2024.
Maryam Aziz1, Emily C O'Brien1,2, Jay B Lusk3
1Department of Population Health Sciences, Duke University School of Medicine, Durham NC, United States of America.
Medrxiv : the Preprint Server for Health Sciences
|August 8, 2025
Summary
Reporting of race and ethnicity in clinical research has improved but remains incomplete. Observational and late-phase studies show significant shortfalls in data collection and reporting.
Area of Science:
- Clinical research methodology
- Health equity
- Data transparency
Background:
- Transparent reporting of race and ethnicity in clinical research is crucial for identifying health inequities.
- Incomplete data limits the evaluation of diverse population inclusion in studies.
Purpose of the Study:
- To analyze factors associated with race and ethnicity reporting in clinical studies.
- To track trends in race and ethnicity reporting on ClinicalTrials.gov.
Main Methods:
- Cross-sectional analysis of 58,163 interventional and observational studies from 2009-2024.
- Multivariable logistic regression to identify study characteristics linked to reporting race and ethnicity.
Main Results:
- Nearly half of studies did not report race or ethnicity. Reporting of both increased from 7.4% to 54.6% between 2013 and 2024.
- Observational studies and Phase 4 trials had lower odds of reporting race/ethnicity. NIH-funded studies were more likely to report than industry-funded studies.
- White participants were consistently over 50% of reported race data; Asian participant proportions declined, and Black participant proportions fluctuated. 'Not Hispanic or Latino' comprised over 80% of reported ethnicity.
Conclusions:
- Race and ethnicity reporting on ClinicalTrials.gov has significantly improved but is not yet complete.
- Deficiencies persist, particularly in observational studies and later trial phases, hindering comprehensive health equity assessments.
Keywords:
Clinical ResearchClinical TrialsDiversityEthnicityRaceRace/EthnicityRecruitmentRepresentationMore Related Videos
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