Reporting of Race and Ethnicity in Pediatric Trials Increased from 2011-2020

Chris A. Rees, MD, MPH

A new investigation revealed that the number of published pediatric clinical trials that reported participant race and ethnicity increased from 2011 to 2020.

Despite this, participant race and ethnicity were still underreported, and disparities existed in pediatric clinical trial enrollment of American Indian/Alaska Native, Asian, and Native Hawaiian/Pacific Islander Children.

Previous studies indicated that participants’ race and ethnicity were often not reported in clinical trials, with the underrepresentation of Black patients in therapeutic research being observed.

Investigators led by Chris A. Rees, MD, MPH, Division of Pediatric Emergency Medicine, Emory University School of Medicine, noted that understanding trial enrollment patterns as they relate to race and ethnicity is necessary for addressing health care inequities in pediatric clinical trials.

As such, Rees and colleagues conducted a cross-sectional study that assessed participant race and ethnicity in pediatric clinical trial published from 2011 to 2020.

The Methods

The study utilized data from pediatric clinical trials published in 5 leading pediatric journals and 5 leading general medical journals.

This included JAMA Pediatrics, The Lancet Child & Adolescent Health, Pediatrics, the Journal of Adolescent Health, the Journal of Pediatrics, the New England Journal of Medicine, The Lancet, JAMA,BMJ, and PLoS Medicine.

The team used the 2019 annual estimate of population sizes from the US census at the national, state, and country levels for children and adolescents aged 0 to 18 years to compare trial enrollment by race and ethnicity.

Articles were included if they reported the results of clinical trials that exclusively enrolled participants in this age or if the median or mean age of participants was less than or equal to 18 years.

Investigators queried PubMed to identify all published articles in the selected journals before using key search terms to extract articles likely to report pediatric clinical trials.

The Findings

A total of 612 articles that reported on pediatric clinical trials were included in the study, with a total of 565,618 participants.

Of these articles, 486 (79.4%) reported participant race while 338 (55.2%) reported participant ethnicity.

Investigators observed an 7.9% per year increase in the relative rates of reporting of participant race from 2011 to 2020 (95% CI, 0.2%-16.3% per year) and an reporting of ethnicity increased by 11.4% per year (95% CI, 4.8%-18.4% per year).

Among the articles reporting race and ethnicity, the team noted that the method of assignment was not reported in 261 of 511 articles (51.1%) and 207 of 359 articles (57.7%).

Notably, African American children were enrolled proportionally more than the US population of African American children (odds ratio [OR], 1.88; 95% CI, 1.87-1.89), and Hispanic/Latino children were enrolled commensurately with the US population of Hispanic/Latino children (OR, 1.02; 95% CI, 1.01-1.03).

Meanwhile, 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 enrolled significantly less compared with the respective US populations of these groups, while White children were enrolled less than expected (OR, 0.84; 95% CI, 0.84-0.85) yet represented 188 156 (46.0%) of participants in trials reporting race or ethnicity.

Investigators hypothesized that improved enrollment rates among Hispanic/Latino populations were a result of the addition of recruitment materials in participants’ preferred language and the employment multilingual staff.

They added that, broadly speaking, “the creation of culturally sensitive materials to explain trial details may be associated with increased recruitment and retention of pediatric participants in trials.”

The study, "Reporting of Participant Race and Ethnicity in Published US Pediatric Clinical Trials From 2011 to 2020," was published online in JAMA Pediatrics.