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Study: Asian, Black, Hispanic children underrepresented in clinical trials

March 14, 2023

Asian American, Black and Hispanic children are underrepresented in clinical trials, according to a new study.

“Although race is a social construct without biological basis, representative inclusion in clinical trials is critical to analyze the impact of structural barriers and ensure the external validity of results,” authors wrote in “Racial and Ethnic Reporting and Representation in Pediatric Clinical Trials” (Brewster RCL, et. al. Pediatrics. March 14, 2023). “Shortcomings in trial diversity exacerbate longstanding racial and ethnic disparities in health care access and outcomes.”

A team of researchers analyzed 1,183 clinical trials from Clinicaltrials.gov that included children from October 2007-March 2020. They found the rate of those reporting on race and ethnicity increased form 28% in 2008 to 87% in 2018. Government-funded trials were most likely to report these demographics.

“Ultimately a necessary step in understanding and advancing trial diversity is complete, transparent and precise reporting,” author Ryan C.L. Brewster, M.D., a pediatrics resident at Boston Children’s Hospital, said in a video abstract for the study. “In other words, we cannot fix what we do not know.”

Among trials with race and ethnicity data, the median proportional enrollment was 66% for White children, 12% for Black children, 7% for Hispanic Children, 0.6% for Asian American children and 0% for American Indian children. Enrollment of Hispanic children was the only group to increase significantly.

Compared to the U.S. population, Asian, Black and Hispanic children were underrepresented. Comparing enrollment to prevalence of disease, Asian American and Hispanic children were underrepresented most often. Black children were underrepresented in autism and diabetes trials and overrepresented in asthma trials, according to the study.

Authors laid out steps to improve diversity in trials, including more rigorous standards for trial approval and publication, financial reimbursement for participation, improved recruitment, multilingual protocols and partnerships with marginalized communities.

“Addressing these challenges requires greater accountability across the biomedical research ecosystem from funders to policymakers,” Dr. Brewster said. “As structural racism becomes increasingly recognized as a public health crisis, it has become a matter of both science and justice to ensure clinical trials are reflective of and benefit all children.”

Authors of a related commentary also stressed the importance of creating a more diverse workforce.

“We must be as equally proactive about changing the culture of the institutions in which we work as we are about developing pipeline programs, opportunities for advancement, and retention practices that expand inclusion in our workforce,” they wrote.

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