Underrepresentation of Hispanics in clinical trials for liver cancer in the United States over the past 20 years.

ABSTRACT

IMPORTANCE Accurate representation of racial and ethnic population subgroups in clinical trials is fundamental to ensure universal effectiveness of new therapies as well as to decrease disparities in oncology care. OBJECTIVE: To determine whether Hispanic people are underrepresented in Phase I and II clinical trials for liver cancer in the United States. PARTICIPANTS: A database search was performed in clinicaltrials.gov for interventional liver cancer studies based only in the US with reported results from September 1, 2002, to February 1, 2023. A total of 37 trials with 963 total patients met inclusion criteria and were included for further analysis. Proportion of total patients by race/ethnicity was calculated for non-Hispanic white, non-Hispanic black, Asian, Hispanic, and American Indian/Alaska Native subpopulations. The age-adjusted incidence rates of liver and intrahepatic bile duct were acquired from the National Cancer Institute, Surveillance, Epidemiology, and End Results Program. RESULTS: Liver cancer incidence rates (per 100,000 people) were highest in Indians/Alaska Native people (18.8 cases) followed by Hispanic people (15.1 cases), then Asian people (12.5 cases), then non-Hispanic black people (11 cases), and non-Hispanic white people (7.5 cases). From a total of 91 phase I or II clinical trials for liver cancer in the US, 41% reported race/ethnicity enrollment data; among these, 62.8% of patients were non-Hispanic White, 15.9% were non-Hispanic black, 8.8% were Hispanic, 12.7% Asian, and 0.5% American Indian/Alaska Native. CONCLUSIONS AND RELEVANCE Less than half of phase I or II clinical trials for liver cancer in the US in the last 20 years reported race/ethnicity data to clinicaltrials.gov. Compared to the relative incidence rate of liver cancer, non-Hispanic black people and Hispanic people are underrepresented in these clinical trials.