Most racial, ethnic groups underrepresented in pediatric clinical trials
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Most racial and ethnic groups were underrepresented in pediatric clinical trials conducted in the United States, while Black children were overrepresented based on U.S. population proportions, according to recent data.
Specifically, researchers observed disparities in trial enrollment among American Indian/Native Alaskan, Asian and Native Hawaiian/Pacific Islander children. The findings were presented at the American Academy of Pediatrics National Conference and Exhibition.
“Black children were enrolled 88% more than expected, based on the U.S. population. The higher representation of Black children compared to the U.S. population suggests inclusive research practices that could be extended to other historically disenfranchised racial and ethnic groups,” Chris A. Rees, MD, MPH, a pediatric emergency medicine physician at Children’s Healthcare of Atlanta and assistant professor of pediatrics and emergency medicine at Emory University, told Healio Primary Care.
Rees and colleagues conducted a cross-sectional study of 612 articles published in leading pediatric and general medical journals from Jan. 1, 2011, to Dec. 31, 2020. The articles included 565,618 participants. The researchers compared the number of children in each race and ethnicity group with U.S. Census populations.
Overall, 79.4% of the articles reported participant race and 63.4% reported participant ethnicity, according to the researchers. Between 2011 and 2020, reporting of race increased by 7.9% (95% CI, 0.2-16.3), while reporting of ethnicity increased by 11.4% (95% CI, 4.8-18.4).
The proportion of Black children in clinical trials exceeded their population proportion in the U.S. (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 American/Pacific Islander (OR = 0.66, 95% CI 0.61-0.72) children were enrolled at a significantly lower rate based on the U.S. population, according to Rees and colleagues. Also, white children were enrolled at a lower rate than expected (OR = 0.84, 95% CI 0.84-0.85), but they still accounted for 46% of participants in trials reporting race or ethnicity.
Trials conducted in Arizona, Tennessee, Georgia, West Virginia and New Hampshire had the lowest mean diversity indices, and those conducted in California, Maine, Illinois and North Carolina had the highest diversity indices, according to the researchers. The findings differ from research on enrollment in adult clinical trials, which have a lower proportion of Black, Hispanic and Latino adults, Eric Fleegler, MD, MPH, a coauthor and associate physician in the division of emergency medicine at Boston Children’s Hospital and assistant professor of pediatrics and emergency medicine at Harvard Medical School, told Healio Primary Care.
“Equitable clinical trial enrollment is an actionable step that investigators can take to begin to address health inequities in the U.S.,” he said. “Results from clinical trials that lack participants who are people of color may not be generalizable to all populations that may benefit from trial results.”
Reference:
Race and ethnicity of children enrolled in clinical trials not representative of the United States as a whole: study abstract. https://www.aap.org/en/news-room/news-releases/aap/2021/race-and-ethnicity-of-children-enrolled-in-clinical-trials--not-representative-of-the-united-states-as-a-whole-study-abstract/. Published Oct. 8, 2021. Accessed Oct. 8, 2021.