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

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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.

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