Racial and Ethnic Diversity in Clinical Studies Reported to ClinicalTrials.gov, 2009-2024.

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.