Latinos are least reported enrollment group in clinical trials: study

According to a new study published Monday by The Lancet.

Looking at US-based clinical trial enrollment data reported to the database between March 2000 and March 2020, the researchers said that only about 43% of trials collected data on race. and ethnicity of trial participants. Of those who did, minority groups “are underrepresented”, according to the study, adding that the researchers found “modest improvement over time”.

Industries across the United States have, during the coronavirus pandemic, faced a consideration for diversity, equity and inclusion, particularly in healthcare, where the impacts of the spread of the virus highlighted the existing disparities. As viral data showed patients from diverse backgrounds reacted to COVID-19 infections in different ways, scientists pushed for increased diversity in vaccine trials to assess potential limitations.

A new study indicates that white participants were overrepresented in US-based clinical trials between March 2000 and March 2020, while Latinos, Asians and Native Americans were underrepresented. Above, swabs from patients participating in a COVID-19 vaccine clinical trial wait to be tested at the UW Medicine Retrovirology Lab in Seattle, Washington on February 12, 2021.
Karen Ducey/Getty Images

According to the study published on Monday, reporting of race and ethnicity in US-based clinical trials has been “historically poor” but “increasing modestly”. Of the 20,692 clinical trials that reported results to over the 20-year study period, 8,871 represented participants’ race or ethnicity, although the researchers said most had collected data on the identification of participants as male or female. Less than 25% of the clinical trials reviewed for the study focused on the five major racial and ethnic groups in the United States, which the researchers identified as white, Hispanic/Latino, black, Asian, and Native American.

More than half of all participants in studies that tracked race and ethnicity were white, with white representation “exceeding the U.S. Census estimate of white representation among the U.S. population.”

“Latinos, Asians, and Native Americans were all underrepresented relative to their American populations,” the researchers wrote, “with the largest gap observed for Latinos.” In contrast, “median black enrollment is not statistically lower than their U.S. population.”

Trials funded by industry or academic groups reported the race and ethnicity of participants less often than government-funded research, with a steady increase in reports of race and ethnicity between 2008 and 2020 , according to the study. The researchers awarded funding for their study to Stanford Medical Scholars Research Funding, the National Heart, Lung, and Blood Institute, the American Heart Association/Robert Wood Johnson Medical Faculty Development Program, and the National Institutes of Health.

While previous studies assessing reports of race and ethnicity in clinical trials have been smaller or otherwise limited in scope, the researchers wrote that they believe their results constitute “the largest study of racial diversity/ ethnicity in clinical trials”. They noted that their study had some limitations, including being limited to clinical trials registered through and the lack of reporting on race and ethnicity for the majority of trials registered through the platform on the 20 year period. The different ways in which Latino participants are considered in some clinical studies also limited study results, the researchers said.

According to the U.S. Food and Drug Administration (FDA), involving people from diverse backgrounds in clinical studies “is critical to advancing health equity.” The underrepresentation of minority groups in clinical trials “is concerning because people of different ages, races, and ethnicities may respond differently to certain medical products,” the FDA says on its Clinical Trial Diversity page.

The U.S. Department of Health and Human Services’ Office of Minority Health (OMH) says individuals “of different ages, races, and ethnicities may respond differently to certain medical products” and notes that the FDA shared publicly certain demographic information about clinical trial participants. for drugs approved by the FDA since 2015.

Newsweek contacted the US Department of Health and Human Services’ Office of Minority Health for comment.


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