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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.
Importance:
A lack of transparent reporting of race and ethnicity in clinical research limits the ability to identify health inequities and evaluate to what extent clinical research includes diverse populations.
Objective:
To identify study characteristics associated with reporting race and ethnicity of clinical study participants and to document temporal trends in race and ethnicity reporting on clinicaltrials.gov.
Design:
Cross-sectional analysis of interventional trials and observational studies from 2009-2024; multivariable logistic regression assessed study-level factors associated with reporting race and ethnicity.
Setting:
Global registry of clinical studies (clinicaltrials.gov).
Participants:
58,163 studies with posted results and without early termination.
Exposures:
Study characteristics: sponsor trial phase, study type, and country.
Main Outcomes And Measures:
Reporting of race, reporting of ethnicity, reporting of both.
Results:
Among 58,163 studies (mean enrollment=1,215 participants), 44.8% did not report race or ethnicity to the repository (mean enrollment=1,481 participants). The proportion of studies reporting both race and ethnicity rose from 7.4% in 2013 to 54.6% in 2024. In multivariable models, observational studies had lower odds of reporting race and ethnicity (odds ratio[OR]=0.55, 95% confidence interval[CI]=0.49-0.61) compared with interventional trials. Phase 4 trials were least likely phase to report race and ethnicity (OR=0.32; CI=0.29-0.35), and studies with only National Institute of Health funding were more likely to report race and ethnicity compared to studies with any industry funding or sponsorship (OR=1.70, CI=1.61-1.79). For studies that reported race, White participants comprised ≥50% each year based on study-level percentages; proportions of Asian participants declined, and Black participants fluctuated. 'Not Hispanic or Latino' remained ≥80% of reported ethnicity annually.
Conclusions And Relevance:
Race and ethnicity reporting on clinicaltrials.gov has improved markedly yet remains incomplete, with shortfalls in late-phase and observational studies.
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