Asian, indigenous, Latino patients underrepresented in US clinical trials of biologics
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Asian, American Indian, Alaska Native, Latino and Hispanic patients are underrepresented in U.S. clinical trials for new drugs and biologics, compared with national census figures, according to a research letter published in JAMA.
Meanwhile, trial participation rates among Black and white patients were generally consistent with, or above, U.S. Census figures from 2015 to 2019, the researchers wrote.
“Concerns have been raised over racial and ethnic representation in clinical trials,” Milena Lolic, MD, MS, of the FDA Office of the Commissioner, in Silver Spring, Maryland, and colleagues wrote. “In 2015, the U.S. Food and Drug Administration (FDA) launched the Drug Trials Snapshots program, a transparency initiative highlighting demographics in the pivotal clinical trials that supported FDA approval of new molecular entities or original biologics. Recently, the FDA published a summary report of aggregated global demographic data from the trials that were the basis for snapshots published between 2015 and 2019.”
Using that database, Lolic and colleagues analyzed the representation of racial and ethnic populations in U.S. clinical trials for new molecular drugs and original biologics. The researchers pooled demographic information from 517 trials, with 102,596 participants from U.S. sites, published between 2015 and 2019, with self-reported race and ethnicity were grouped based on FDA guidance. Racial categories were American Indian or Alaska Native, Asian, Black or African American, white and other, while patients’ ethnicity was described as Hispanic or Latino, or not Hispanic or Latino.
The researchers collected trial site information from identification listings in each trial report and used this data to define the U.S. population subset. Meanwhile, annual census data were obtained from the U.S. Census Bureau. Lolic and colleagues performed a descriptive analysis of these data, comparing mean and annual proportions found in the trials and Census figures.
According to the researchers, the proportion of Asian individuals across the clinical trials ranged from 2% to 3% of U.S.-based participants, representing a mean of 1.6%, despite making up 5.9% of the U.S. Census population during the same time period. American Indian or Alaska Native participants made up 0.4% to 0.6% of participants, for a mean 0.52%, compared with 1.3% in the Census. Yearly participation rates for both groups were lower than the census levels, the researchers wrote.
Black or African American participation ranged from 15% to 19%, for a mean 16.3%, compared with 13.4% in the Census population. These yearly participation rates were consistently at or above the Census level, the researchers wrote. Meanwhile, the proportion of white participants ranged from 76% to 81%, for a mean of 78.3%, compared with 76.3% in the census. Annual participation rates for white patients were lower than the census level in just 1 of 5 years studied.
Regarding ethnicity, Hispanic or Latino participation ranged from 10% to 21% across the trials, with a mean of 15.3%, compared with 18.5% in the census figures. Yearly participation rates for this population were lower than the census level in 3 out of the 5 years studied. However, about 7% to 13% of ethnicity data were missing, according to the researchers.
“The mean and yearly participation rates were at or above the U.S. Census level for Black or African American populations but not for other racial or ethnic minority groups, similar to a recent publication,” Lolic and colleagues wrote. “Although comparing participation in clinical trials by racial and ethnic groups with the census alone is not a definitive assessment, the low proportions of some racial and ethnic groups in these data highlight the need to increase diversity in clinical trial participation in the U.S.”
“This study is limited to 5 years’ worth of data collected only from trials conducted for new molecular entities and original biologics,” they added. “Additionally, data on ethnic representation were not always complete. A comparison of trial participation based on disease prevalence and epidemiology is needed to provide a more detailed assessment of diversity.”
Perspective
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Inclusion of under-represented populations in clinical trials has been a long-standing concern both within the U.S. and worldwide. In this study the authors reviewed participation of racial and ethnic populations at U.S. sites to evaluate the extent to which U.S. trial participants represented the diversity of the U.S. populations.
The authors concluded that the proportion of Black or African American participants was higher than the Census level, whereas levels were lower for other racial and ethnic minority groups (Asian, American Indian/Alaska Native).
Outcomes are often more severe in racial and ethnic minority populations, and disparities are often seen in access to emerging therapies; comparisons to Census level data may misrepresent this disparity. A more nuanced approach would necessitate a comparison of the proportions of clinical trial participation compared to the disease prevalence within these populations. This would also provide information on the efficacy and safety of therapies within at-risk populations, and educate both patients and providers on the availability of these emerging therapies.
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