Race and ethnicity of children enrolled in clinical trials not representative of the United States as a whole: study

When conducting pediatric clinical trials, the scientific process is best served when participants come from diverse racial and ethnic backgrounds, so that conclusions are more likely to be generalizable to a broad population. Yet, according to an analysis of articles on U.S. pediatric clinical trials, Black children were enrolled at a proportionally higher rate than their representation in the U.S. population, while other populations were under-represented.

Researchers will present the study abstract, “Race and Ethnicity in Published Pediatric Clinical Trial Enrollment in the United States, 2011-2020,” during the virtual American Academy of Pediatrics 2021 National Conference & Exhibition.

“Our study identifies key areas in which we, as a pediatric research community, can improve enrollment in clinical trials to be more equitable for all groups,” said study author Chris A. Rees, MD, MPH, pediatric emergency medicine physician at Children’s Healthcare of Atlanta and assistant professor of pediatrics and emergency medicine at Emory University, who performed this study along with researchers from Boston Children’s Hospital.

“Results from clinical trials that lack American Indian, Alaska Native, Asian, and Native American-Pacific Islander participants may not be generalizable to all populations that may benefit from trial results,” he said.

The cross-sectional study reviewed 612 articles published in five leading general pediatric and five leading general medical journals from January 1, 2011-December 31, 2020. Researchers determined the reporting of participant race and ethnicity in published clinical trial results, comparing the number of children enrolled with U.S. Census populations of pediatric racial and ethnic groups.

Black children were enrolled in higher proportions than their representation in the United States. Hispanic and Latino children were enrolled commensurate with their population, and American Indian, Alaska Native, Asian, and Native American-Pacific Islander children were enrolled significantly less relative to their population, the authors found. White children were enrolled less than expected based on their representation in the U.S. population, but made up 46% of participants in trials reporting race or ethnicity. More research is needed to determine the cause of these differences, but authors hypothesize they may be due to the locations where pediatric clinical trials are performed, the types of diseases and conditions that are studied, or may represent disparities in the trial enrollment process.

Researchers also observed that a substantial number of trials did not report participant race or ethnicity at all.

Pediatric clinical trials conducted exclusively 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, indicating that the representativeness of clinical trials may differ by state.