VIDEO: Women, Black patients underrepresented in US-based clinical trials for LT
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Key takeaways:
- Compared with the general U.S. population, Asian participants were overrepresented in clinical trials, while Black and American Indian participants were underrepresented.
- Overall, women were underrepresented.
WASHINGTON — In a Healio video exclusive, Saqr Alsakarneh, MD, MSc, describes “significant disparities” in race, ethnicity and sex among participants enrolled clinical trials for liver transplantation in the U.S.
“Liver transplantation is a critical intervention for patients with end-stage liver disease and it offers them actually a new lease on life,” Alsakarneh, a second-year internal medicine resident at University of Missouri-Kansas City School of Medicine, told Healio. “However, given the importance of this intervention, there has been a lack of clarity surrounding inclusion of some demographic groups and minorities in these clinical trials in the United States.”
Using the NIH website, researchers analyzed demographic data from 69 completed U.S.-based LT clinical trials, which included 6,990 patients, to assess participation of women and ethnic and racial minority groups. Most of the trials were funded by universities and organizations (57%), while the NIH funded only 13%.
Although white participants appeared to be equally represented to the general U.S. population, (75.9%; 95% CI, 74.1-77.7), Asian participants were overrepresented (9.3%; 95% CI, 8.1-10.5) and Black (7.8%; 95% CI, 6.7-8.9) and American Indian (0.4%; 95% CI, 0.1-0.6) participants were underrepresented. By ethnicity, Hispanic participants were underrepresented (13.3%; 95% CI, 12.2-14.5) independent of the census year.
Results also showed Asian participants (15%) were overrepresented threefold in industry-funded trials. In NIH-funded trials, white participants (83.8%) were overrepresented and Black participants (4.1%) were underrepresented compared with the general U.S. population. Women were underrepresented (31.3%; 95% CI, 30-32.3) in all clinical trials.
“Our study revealed significant disparities in the liver transplantation clinical trials in the United States, which emphasizes the importance and needs of addressing these racial disparities,” Alsakarneh said. “It’s not just about equitable representation of patients — it’s about ensuring that every patient has equal access to lifesaving treatment like liver transplantation.”
He continued: “We urge medical, surgical and community leaders to join hands on tackling these disparities.”
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Alsakarneh S, et al. Gender and racial disparities in liver transplantation in the United States: Analysis from 69 clinical trials. Presented at: Digestive Disease Week; May 18-21, 2024; Washington (hybrid).
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