Related Experiment Video
Updated: May 31, 2026
09:55
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'Brien1,2, Jay B Lusk3
1Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, USA.
BMJ Open Quality
|May 29, 2026
Summary
Reporting of race and ethnicity in clinical research has improved but remains incomplete. Observational and late-phase studies show significant shortfalls, hindering efforts to identify health inequities.
Area of Science:
- Clinical research informatics
- Health equity research
- Biomedical data science
Background:
- Transparent reporting of race and ethnicity in clinical research is crucial for identifying health disparities.
- Incomplete data limits the assessment of diverse population inclusion in studies.
- ClinicalTrials.gov is a key repository for tracking these trends.
Purpose of the Study:
- To identify characteristics of clinical studies associated with race and ethnicity reporting.
- To analyze temporal trends in race and ethnicity reporting on ClinicalTrials.gov.
- To evaluate the completeness of demographic data in clinical research.
Main Methods:
- Cross-sectional analysis of 58,163 interventional trials and observational studies from 2009-2024.
- Multivariable logistic regression to assess factors influencing race and ethnicity reporting.
- Analysis of study characteristics including sponsor, trial phase, study type, and funding source.
Main Results:
- 44.8% of studies did not report race or ethnicity.
- The proportion of studies reporting both increased from 7.4% (2013) to 54.6% (2024).
- Observational studies (OR 0.55) and Phase 4 trials (OR 0.32) were less likely to report demographic data. Studies funded solely by the National Institutes of Health were more likely to report (OR 1.70).
Conclusions:
- Race and ethnicity reporting on ClinicalTrials.gov has significantly improved but is still incomplete.
- Shortfalls persist in late-phase trials and observational studies, impacting health equity assessments.
- Continued efforts are needed to ensure comprehensive demographic data collection and reporting.
More Related Videos
14:43A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
Published on: January 12, 2018
06:55Inverse 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
01:16Clinical 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...
There are four phases in a clinical trial. A phase one...
01:11Clinical 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...
01:12Hazard 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...
For example, in a clinical trial evaluating a...
01:12Statistical 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...
01:29Bias 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:
01:14Changes 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...
Albinism
Albinism is a genetic disorder that affects (completely or partially) the coloring of skin, hair, and eyes. The defect is primarily...