Evidence map›Paper›PMID 42215042›Full record

ArticleBMJ open quality2026

Racial and ethnic diversity in clinical studies reported to ClinicalTrials.gov, 2009-2024.

Maryam Aziz, Emily C O'Brien, Jay B Lusk, Sudarshan Krishnamurthy, Vani Garcha, M Alan Brookhart, Robert M Califf, Michael D Green

Abstract read
In one paragraph

Article in BMJ open quality, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Maryam AzizDepartment of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, USA.
Emily C O'BrienDepartment of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, USA.
Jay B LuskDepartment of Family Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Sudarshan KrishnamurthyDepartment of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Vani GarchaDepartment of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, USA.
M Alan BrookhartDepartment of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, USA.
Robert M CaliffDuke University Duke Clinical Research Institute, Durham, North Carolina, USA.
Michael D GreenDepartment of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, USA michael.d.green@duke.edu.ORCID 0000-0002-4982-8154

Funding

NIA NIH HHS F99-AG088695
6 · The paper itself

Abstract

objectiveA 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. Our objectives are: (1) to identify study characteristics associated with reporting race and ethnicity of clinical study participants and (2) to document temporal trends in race and ethnicity reporting on ClinicalTrials.gov.

designCross-sectional analysis of interventional trials and observational studies from 2009 to 2024; multivariable logistic regression assessed study-level factors associated with reporting race and ethnicity.

settingGlobal registry of clinical studies (ClinicalTrials.gov).

participants58 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.

resultsAmong 58163 studies (mean enrolment=1215 participants), 44.8% did not report race or ethnicity to the repository (mean enrolment=1481 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 (OR 0.55, 95% CI 0.49 to 0.61) compared with interventional trials. Phase 4 trials were least likely phase to report race and ethnicity (OR=0.32; 95% CI 0.29 to 0.35), and studies with only National Institute of Health funding were more likely to report race and ethnicity compared with studies with any industry funding or sponsorship (OR=1.70, 95% CI 1.61 to 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.

conclusionsRace and ethnicity reporting on ClinicalTrials.gov has improved markedly yet remains incomplete, with shortfalls in late-phase and observational studies.

Indexed as

Clinical Trials as TopicCultural DiversityEthnicityRacial GroupsCross-Sectional StudiesHumansLogistic ModelsRegistriesCLINICAL TRIALSHealth EquityHealth policyPharmacoepidemiologySocial Conditions

Identifiers

PMID42215042
PMCPMC13223629

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.