Black, Latino patients underrepresented in ‘high-impact’ cirrhosis clinical trials in US
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WASHINGTON — Black and Latino patients are underrepresented in cirrhosis clinical trials, underpinning the need for systematic improvement, according to research presented at The Liver Meeting.
“Almost 5 million adults in the United States live with chronic liver disease, and cirrhosis incidence is currently rising. We also know that there are racial and ethnic disparities in cirrhosis-related mortality,” Nneka Ufere, MD, a transplant hepatologist at Massachusetts General Hospital and Harvard Medical School, said at The Liver Meeting media briefing. “As of 2019, the age-adjusted, cirrhosis-related mortality was highest among U.S. adults of American Indian and Alaskan Native background, as well as Hispanic backgrounds, and they actually represented the fourth and seventh leading causes of death in those populations, respectively.”
Seeking to understand the reporting of sex, race and ethnicity in cirrhosis clinical trials, Ufere and colleagues conducted a systematic review of 133 randomized controlled trials (15 U.S.-based, 118 international) that included 20,870 adult participants with cirrhosis from 2000 to 2021.
Researchers identified enrollment data on gender in 100% of U.S.-based trials compared with 99% of international-based trials. Women comprised 31% of study participants (33% U.S. vs. 30% international), with female trial enrollment paralleling the sex composition of cases of cirrhosis in the U.S. (31% vs. 27%).
Further analysis revealed data on race and ethnicity in 9% of trials (53% vs. 3%). In U.S. trials, 83% of participants were white, 6% were Black, 5% were Latino, 0.6% were Asian and 5% were other. Two U.S. trials reported the inclusion of American Indian/Alaska native or Native-Hawaiian/Pacific-Islander participants, and 75% of U.S. trials that included participants of Hispanic origin confused Hispanic/Latino ethnicity with race.
Compared with the proportion of cirrhosis cases in the U.S., cirrhosis trials underrepresented Black (29% vs. 6%) and Latino (34% vs. 5%) participants.
“Racial and ethnic minorities, particularly those from American Indian and Alaskan Native backgrounds, are underrepresented in high-impact U.S. cirrhosis clinical trials,” Ufere concluded. “There’s an ongoing paucity of reported racial and ethnic demographic data among clinical trials enrolling patients with cirrhosis both in the United States and internationally.”
She added, “It’s clear that barriers to clinical trial enrollment of racial and ethnic minority patients need to be systematically investigated to improve representation.”
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Ufere N, et al. Underrepresentation of racial and ethnic minorities in cirrhosis clinical trials. Presented at: AASLD The Liver Meeting; Nov. 4-8, 2022; Washington (hybrid).
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