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Assessment of Child Anthropometry in a Large Epidemiologic Study
Published on: February 2, 2017
Racial and ethnic disparities in clinical trials for pediatric obesity
Catherine G Coughlin1, Emilie S Zoltick2, Fatima Cody Stanford3
1Division of Emergency Medicine, Boston Children's Hospital, Boston, Massachusetts, USA.
Insights
Historically marginalized racial and ethnic groups, except for Black and Hispanic children, were underrepresented in pediatric obesity clinical trials. Improved diversity and race/ethnicity data reporting are crucial for equitable research.
Area of Science:
- Clinical research
- Pediatric health
- Health equity
Background:
- Pediatric obesity is a significant public health concern.
- Clinical trials are essential for developing effective obesity treatments.
- Ensuring diverse participant representation is critical for generalizability and equity.
Purpose of the Study:
- To assess the representation of historically marginalized racial and ethnic groups in U.S. pediatric obesity clinical trials.
- To identify disparities in enrollment compared to disease prevalence.
- To highlight gaps in race and ethnicity data collection and reporting.
Main Methods:
- Cross-sectional analysis of pediatric obesity trials registered in ClinicalTrials.gov.
- Included trials completed between January 2013 and August 2023 in the United States.
- Calculated enrollment-prevalence disparity (EPD) to quantify underrepresentation.
Main Results:
- 260 trials met eligibility; 49.2% reported race/ethnicity data.
- White, Hispanic, and Black children's enrollment generally reflected disease burden.
- Asian, American Indian/Alaska Native, and Native Hawaiian/Pacific Islander children were significantly underrepresented (EPD < 0).
Conclusions:
- Significant underrepresentation of several marginalized groups in pediatric obesity trials indicates a need for improved participant diversity.
- Substantial gaps exist in the documentation and reporting of race and ethnicity information.
- Concerted efforts are necessary to enhance data collection and ensure adequate representation in clinical trials.
Objective:
The objective of this study was to examine the representation of historically marginalized racial and ethnic groups in pediatric obesity clinical trials.
Methods:
We performed a cross-sectional analysis of clinical trials in pediatric obesity (participants aged ≤18 years) that were registered in ClinicalTrials.gov, were completed from January 2013 to August 2023, and were conducted in the United States. We quantified disparities in trial enrollment by calculating the enrollment-prevalence disparity (EPD) for each racial and ethnic group.
Results:
A total of 260 trials met eligibility criteria, of which 128 trials (49.2%) reported race and/or ethnicity data. Enrollment of White, Hispanic, and Black children roughly reflects disease burden in these populations. However, relative to disease burden, Asian (EPD, -3.7%; IQR, -3.7% to 1.8%; p < 0.0001), American Indian and Alaska Native (EPD, -2.1%; IQR, -2.1% to -2.1%; p < 0.0001), and Native Hawaiian or other Pacific Islander (EPD, -0.6%; IQR, -0.6% to -0.6%; p < 0.0001) children were significantly underrepresented in these trials.
Conclusions:
With the exception of Black and Hispanic children, historically marginalized racial groups were underrepresented in pediatric obesity trials, signifying a need to improve diversity of participants in these trials. Additionally, there are substantial gaps in the documentation of race and ethnicity information. Concerted efforts are needed to ensure adequate reporting of race and ethnicity information in clinical trials.
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