Reporting of Race and Ethnicity in Clinical Trials Enrolling Youth is Improving, but Diverse Enrollment Continues to Fall Short: Study

The reporting of race and ethnicity characteristics in clinical trials enrolling children under age 18 significantly improved between 2007 and 2018, but gaps remain in achieving equitable enrollment of racial and ethnic children relative to the general U. S. population, a study finds. The study, “Race and Ethnicity Reporting and Representation in Pediatric Clinical Trials,” published in the April 2023 Pediatrics (published online March 14) analyzed a cross-sectional study of U.S.-based clinical trials registered on ClinicalTrials.gov, finding that clinical trials that enrolled participants under age 18 increased to 87% in 2018, up from 27% in 2007. The median proportional enrollment of Asian children was 0.6%; American Indian, 0%; Black, 12%; Hispanic, 7.1%; and white, 66.4%. Asian, Black and Hispanic participants were underrepresented relative to U.S. population demographics. The authors call for evidence-based and policy solutions to address these disparities, as representative enrollment of racial and ethnic populations in research ensures the generalizability of results and equitable access to novel therapies.

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The American Academy of Pediatrics is an organization of 67,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults.