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Race and ethnicity in clinical trials

Creating a heterogenous cohort in pediatric clinical trials aids in the generalizing of the results and helps ensure that data of efficacy and safety are more accurate. A report looks at data from the past 10 years to see how often race/ethnicity are reported and whether there has been improved inclusion of non-White children.

In order to provide accurate results regarding the safety and efficacy of drugs and devices being tested through clinical trials, a diverse participant pool would work better than one that skewed male and White, for instance. In recent years, a concerted effort has been made to achieve greater parity in clinical trials. A report investigates whether that effort has paid off.1

The investigators performed a cross-sectional study that looked at the articles reporting on pediatric clinical trials in the United States from January 2011 to December 2020. The medical journals used were the top 5 general pediatric and top 5 general medicine. They looked for the reporting of the participants’ race/ethnicity and compared it to the US census population.

A total of 612 studies were included in the study, encompassing 565,618 participants. From that pool, 486 reported the race of participants and 338 reported on participant ethnicity. During the studied period, the relative rates of reporting on the race of participants saw an increase of 7.9% per year (95% CI, 0.2%-16.3% per year) and ethnicity reporting increased by 11.4% per year (95% CI, 4.8%-18.4% per year). In the articles that did report race and ethnicity, method of assignment was not indicated in in 261 of 511 articles (51.1%) and 207 of 359 articles (57.7%), respectively. They found that a higher ratio of Black children was enrolled in trials than the ratio found in the US population. On the other hand, American Indian/Alaska Native (OR, 0.82; 95% CI, 0.79-0.85), Asian (OR, 0.56; 95% CI, 0.55-0.57), and Native Hawaiian/Pacific Islander (OR, 0.66; 95% CI, 0.61-0.72) children were found to be enrolled at significantly less rates when compared to the populations in the United States. Hispanic children were found to be enrolled at a rate that was proportionate with the Hispanic population in the United States (OR, 1.02; 95% CI, 1.01-1.03). The investigators found that White children were enrolled less than had been anticipated, but they still made up 46% of the participants in the studies used.

The investigators concluded that the number of studies that reported the race and ethnicity of participants had increased from 2011 to 2020, but it still remains underreported overall. Some disparities between presence in clinical trials and the actual US populations exist, but the heightened presence of Black children in the studies indicates inclusive research practices that could be an effective way to close the gaps in other groups.


1. Rees C, Stewart A, Mehta S, et al. Reporting of participant race and ethnicity in published US pediatric clinical trials from 2011 to 2020. JAMA Pediatr. March 21, 2022. Epub ahead of print. doi:10.1001/jamapediatrics.2022.0142

This article originally appeared on Contemporary Pediatrics®.