Related Experiment Video

Updated: May 31, 2026

Bridging the Technology Divide in the COVID-19 Era: Using Virtual Outreach to Expose Middle and High School Students to Imaging Technology

Bridging the Technology Divide in the COVID-19 Era: Using Virtual Outreach to Expose Middle and High School Students to Imaging Technology

Published on: September 28, 2022

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

Maryam Aziz¹, Emily C O'Brien^1,2, Jay B Lusk³

¹Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, USA.

BMJ Open Quality

|May 29, 2026

Abstract

Objective:

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. 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.

Design:

Cross-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.

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 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.

Conclusions:

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

Keywords:

CLINICAL TRIALS Health Equity Health policy Pharmacoepidemiology Social Conditions

More Related Videos

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting

Published on: January 12, 2018

Inverse Probability of Treatment Weighting (Propensity Score) using the Military Health System Data Repository and National Death Index

Inverse Probability of Treatment Weighting (Propensity Score) using the Military Health System Data Repository and National Death Index

Published on: January 8, 2020

Related Concept Videos

Clinical Trials

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...

Clinical Trials: Overview

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...

Hazard Ratio

Hazard Ratio

The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial evaluating a...

Statistical Software for Data Analysis and Clinical Trials

Statistical Software for Data Analysis and Clinical Trials

Statistical software is pivotal in data analysis and clinical trials by providing tools to analyze data, draw conclusions, and make predictions. These software packages range from simple data management applications to complex analytical platforms, supporting various statistical tests, models, and simulation techniques. Their significance lies in their ability to handle vast amounts of data with precision and efficiency, enabling researchers to validate hypotheses, identify trends, and make...

Bias in Epidemiological Studies

Bias in Epidemiological Studies

Biases can arise at various stages of research, from study design and data collection to analysis and interpretation. Recognizing and addressing these biases is essential to ensure the validity and reliability of epidemiological findings.Broadly speaking, biases in epidemiology fall into three main categories: selection bias, information bias, and confounding. A more detailed description of possible biases is:

Changes in Skin Color: Clinical Perspectives

Changes in Skin Color: Clinical Perspectives

The first thing a clinician sees is the skin, so the examination of the skin should be part of any thorough physical examination. Most skin disorders are relatively benign, but a few, including melanomas, can be fatal if untreated. A couple of the more noticeable disorders, albinism and vitiligo, affect the appearance of the skin and its accessory organs.
Albinism
Albinism is a genetic disorder that affects (completely or partially) the coloring of skin, hair, and eyes. The defect is primarily...

Articles linked to this work by shared authors, journal, and citation graph.

Neighborhood Socioeconomic Deprivation and Adherence to Diabetic Retinopathy Screening Guidelines.

American journal of ophthalmology·2026

Cardiovascular Multimorbidity and Associated Mortality Among Medicare Beneficiaries Dually Eligible for Medicaid.

Journal of the American Heart Association·2026

Association between GLP-1 receptor agonists and alcohol-related hospitalisations among adults with alcohol use disorder: multi-target trial emulation study.

BMJ open·2026

Observational Comparative Research in Cardiovascular and Brain Health and Disease: A Scientific Statement From the American Heart Association.

Circulation·2026

Association Between Discrimination in Health Care and ASCVD Among Middle-Aged and Older Adults in the United States.

Circulation. Population health and outcomes·2026

Evaluating fitness-for-use of electronic health records in ascertaining baseline characteristics and clinical outcomes in clinical trials: insights from the VESALIUS EHR demonstration project.

Trials·2026

See all related articles