BPCA-Funded Studies Have Racial, Ethnic Diversity

(Reuters Health) – Studies and clinical trials funded by the Best Pharmaceuticals for Children Act (BPCA) generally enroll youth from a variety of racial and ethnic groups at proportions at or above their representation in the population, a new study suggests.

Researchers examined data on 10,918 participants enrolled in 33 BPCA-funded studies of medical devices and drugs conducted from 2008 through June 2020. Researchers compared observed racial and ethnic group representation in these studies with expected proportions based on representation in U.S. Census records.

All studies included in the analysis had enrollment in line with expected enrollment based on the population, with minimal absolute differences between the actual study enrollment and the proportion of various racial and ethnic groups in the population, the researchers write in Pediatrics.

Significantly higher-than-expected study enrollment was found for youth who were white, multi-racial, American Indian, Hawaiian, and Hispanic, with absolute differences ranging from 0.2% to 2.6%.

Significantly lower-than-expected study enrollment was found for youth who were Asian, with an absolute difference of 3.7%, the study also found. The proportion of Black youth in these studies was not statistically different from representation in the population.

When the researchers examined racial and ethnic representation by U.S. Census Region and division, however, they found wide variation in how well enrollment lined up with representation in the population.

Seven of nine census divisions had absolute percentage deviations of at least 5%, and four divisions had absolute percentage deviations of 10% or more, the study found.

Only two divisions – the West North Central Midwest and the West South Central South – had study enrollment with percentage deviations of less than 5% across all racial and ethnic groups.

Asian American youth were underrepresented in all but one census division.

“The data in the study are reassuring, on the whole, but there is still a wide degree of variation in representation by geographic region,” said lead study author Susan Abdel-Rahman, director of health care innovation at Children’s Mercy Research Institute in Kansas City, Missouri.

“We need a mechanism to reinforce accountability for representation within research communities and empower these communities with the tools and strategies that are needed to expand the inclusion of underrepresented patients,” Abdel-Rahman said by email.

One limitation of the study is that researchers lacked data on consent forms to know what languages these documents were offered in, and it’s possible that more studies had options in Spanish than in certain Asian languages, the authors note. Some studies included in the analysis may also have had inaccurate or incomplete information on race or ethnicity for certain participants.

“Most academic centers have Spanish-translated documents, but other languages are less available, and language discordance has been cited as a barrier to clinical trial recruitment,” said Dr. Carolyn Russo of St. Jude Children’s Research Hospital in Memphis, Tennessee.

Improving access to clinical trials for children regardless of race, ethnicity, place of residence, or socio-economic status is critical to cure and prevent disease in all children, Dr. Russo, who wasn’t involved in the study, said by email.

“This means removing the barriers of travel, study burden, cost, and time away from work and school,” Dr. Russo said. “We must also work to develop trust.”

SOURCE: https://bit.ly/328J2Wz Pediatrics, online April 12, 2021.

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