Race and Ethnicity in Clinical Trials
In order to provide accurate results regarding the safety and effectiveness of drugs and devices tested in clinical trials, a diverse group of participants would work better than a group that biases men and whites, for example. In recent years, a concerted effort has been made to achieve greater parity in clinical trials. A report examines whether this effort paid off.1
Investigators conducted a cross-sectional study that examined 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 pediatrics and the top 5 general medicine. They researched the race/ethnicity ratio of the participants and compared it to the US census population.
A total of 612 studies were included in the review, encompassing 565,618 participants. Of this group, 486 reported participant race and 338 reported participant ethnicity. Over the study period, relative rates of participants’ race reporting increased by 7.9% per year (95% CI, 0.2% to 16.3% per year) and reports of ethnic origin increased by 11.4% per year (95% CI, 4.8% to 18.4% per year). In articles that reported race and ethnicity, method of attribution was not reported in 261 of 511 articles (51.1%) and 207 of 359 articles (57.7%), respectively. They found that a higher ratio of black children were enrolled in the trials than the ratio found in the US population. On the other hand, American Indians/Alaska Natives (OR, 0.82; 95% CI, 0.79-0.85), Asians (OR, 0.56; 95% CI, 0. 55-0.57) and Hawaiian/Pacific Islander (OR, 0.66; 95% CI, 0.61-0.72) children were enrolled at significantly lower rates compared to US populations . Hispanic children were found to be enrolled at a rate proportional to the Hispanic population in the United States (OR, 1.02; 95% CI, 1.01-1.03). Investigators found that white children enrolled less than expected, but they still made up 46% of participants in the studies used.
The investigators concluded that the number of studies that reported participants’ race and ethnicity increased from 2011 to 2020, but this remains underreported overall. Some disparities between presence in clinical trials and actual US populations exist, but the increased presence of black children in studies points to inclusive research practices that could be an effective way to fill gaps in other groups.
1. Rees C, Stewart A, Mehta S, et al. Report on the race and ethnicity of participants in pediatric clinical trials published in the United States from 2011 to 2020. pediatrician. 2022 Mar 21. Epub ahead of print. doi:10.1001/jamapediatrics.2022.0142
This article originally appeared on Contemporary Pediatrics®.