Abstract 1944: Racial and ethnic disparities in U.S. clinical trials in liver cancer in the last nineteen years
Authors: Maldonado J. Alberto , Graubard Barry I. , McGlynn Katherine A. , Greten Tim F. , Monge Cecilia 
Published: April 2023

Background: Accurate representation of ethnic/racial population subgroups in clinical trials is fundamental to ensure universal effectiveness of new therapies as well as to decrease disparities in oncology care. In 2020, Hispanic (Hisp) and Non-Hispanic Black (NHB) people constituted 19% and 14% of the U.S. population, respectively. As of 2019, Hisp and NHB proportionally made up 23.2% and 11.1% of hepatocellular carcinoma cases, respectively, and 22.6% and 8.3% of biliary tract cancer cases. We analyzed the enrollment of racial/ethnic groups of liver cancer trials in the U.S in the last twenty years.

Methods: A database search was performed in clinicaltrials.gov for interventional liver cancer studies based only in the U.S. with reported results from 09/2002-08/2022. A total of 3492 trials were identified; studies were excluded if non-interventional (N=168), recruited in a foreign site (N= 2422), results were missing (N=713), or were not liver specific (N=63), resulting in a total of 126 studies. We sought to quantify the enrollment of racial/ethnic subgroups.

Results: From a total of 126 studies, enrolling 5197 patients, 53.2% reported race/ethnicity; amongst these, 57.1% of patients were Non-Hispanic White, 14.5% were NHB, 9.9% were Hisp, 8.5% Asian, 0.4% American Indian and 0.2% Native Hawaiian/Pacific Islander. NIH-funded studies had higher rates of race/ethnicity reporting without reaching statistical significance (65.1% vs 47.0%, p= 0.053). The rate of race/ethnicity reporting between clinical trial phases (I- IV) was not statistically significant (p= 0.70).

Conclusions: 47% of U.S. liver cancer studies in the last twenty years in clinicaltrials.gov did not report race/ethnicity. The relative representation of NHB and Hispanics in these trials is lower than the incidence reported in the U.S. Race/ethnicity reporting in U.S.-based clinical trials may be beneficial.

Table 1: Demographics of U.S-only Clinical Trials of Liver Cancer By Funding By Trial Phase All NIH Non-NIH P- value Phase I or II P- value P- value Trials 126 43 83 - 105 - - Participants 5306 1557 3749 - 3325 - - Race and ethnicity reported 53.2% 65.1% 47.0% 0.053 57.1% 0.70 0.70 Race and Ethnicity NHW* 57.1% 57.7% 56.7% 0.86 60.2% NA NA NHB* 14.5% 11.2% 16.8% 0.07 15.1% NA NA Hisp* 9.9% 13.4% 7.4% 0.30 7.1% NA NA Asian 8.5% 9.9% 7.5% 0.57 7.9% NA NA AI* 0.4% 0.2% 0.5% 0.17 0.4% NA NA NH/PI* 0.2% 0.2% 0.2% 0.76 0.2% NA NA *NHW= Non-Hispanic White, NHB= Non-Hispanic Black, Hisp= Hispanic, AI= American Indian, NH/PI= Native Hawaiian/Pacific Islander

Citation Format: J. Alberto Maldonado, Barry I. Graubard, Katherine A. McGlynn, Tim F. Greten, Cecilia Monge. Racial and ethnic disparities in U.S. clinical trials in liver cancer in the last nineteen years [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 1944.