Mapping Disparities in Clinical Trial Enrollment Among HCC Patients: Insights From Social Determinants of Health
Author(s)
Mikin V Patel, MD, MBA1, Alysha M. McGovern, MBA2, Amy Bolton, BA2, Abimbola O. Williams, MPH, MS2, Osmanuddin Ahmed, MD1;
1University of Chicago, Chicago, IL, USA, 2Boston Scientific, Marlborough, MA, USA
1University of Chicago, Chicago, IL, USA, 2Boston Scientific, Marlborough, MA, USA
Presentation Documents
OBJECTIVES: Hepatocellular carcinoma (HCC) is the most common primary liver malignancy and a leading cause of cancer-related mortality worldwide. Despite treatment advances, outcomes remain poor and may be a result of limited access to care. Understanding the factors influencing clinical trial enrollment among this population is critical to ensuring access to new and emerging therapies. This study evaluated the demographic and socioeconomic characteristics associated with clinical trial participation among Medicare beneficiaries with HCC.
METHODS: The Medicare 5% Standard Analytical Files were used to identify individuals aged 65+ with an HCC encounter from 1/1/2016-12/31/2022. Patients were stratified by clinical trial participation, defined by International Classification of Diseases, Tenth Revision diagnosis code Z00.6. Patient counts were extrapolated to the total Medicare Fee-for-Service population by applying a multiplier of 20. Patient-level data were then linked to 2020 county-level social determinants of health from the Agency for Healthcare Research and Quality (AHRQ) database.
RESULTS: The cohort included 161,440 HCC patients (76.2% White, mean age 73.8 years, mean Charlson Comorbidity Index [CCI] score 8.8). Among these, 7,660 patients (4.7%) participated in clinical trials. Participants had significantly higher mean CCI scores (9.9 vs. 8.7, p<0.001) and were more likely to be White (83.6% vs. 75.9%, p=0.002) than non-participants. Participants were more likely to reside in metropolitan areas (88.0% vs. 83.9%, p=0.033) and in counties with higher socioeconomic indicators, including a median household income ≥$85,081 (22.5% vs. 17.1%, p=0.007) and median home value ≥$348,000 (33.7% vs. 25.1%, p<0.001). Additionally, a greater proportion of participants lived ≤4.0 miles from the nearest emergency department (79.6% vs. 72.4%, p=0.002). No significant sex differences were observed (63.7% vs. 63.8% male, p=0.968).
CONCLUSIONS: Clinical trial participation among Medicare beneficiaries with HCC remains low, with disparities driven by demographic and socioeconomic factors. These findings emphasize the need for improved enrollment strategies to increase access to emerging therapies.
METHODS: The Medicare 5% Standard Analytical Files were used to identify individuals aged 65+ with an HCC encounter from 1/1/2016-12/31/2022. Patients were stratified by clinical trial participation, defined by International Classification of Diseases, Tenth Revision diagnosis code Z00.6. Patient counts were extrapolated to the total Medicare Fee-for-Service population by applying a multiplier of 20. Patient-level data were then linked to 2020 county-level social determinants of health from the Agency for Healthcare Research and Quality (AHRQ) database.
RESULTS: The cohort included 161,440 HCC patients (76.2% White, mean age 73.8 years, mean Charlson Comorbidity Index [CCI] score 8.8). Among these, 7,660 patients (4.7%) participated in clinical trials. Participants had significantly higher mean CCI scores (9.9 vs. 8.7, p<0.001) and were more likely to be White (83.6% vs. 75.9%, p=0.002) than non-participants. Participants were more likely to reside in metropolitan areas (88.0% vs. 83.9%, p=0.033) and in counties with higher socioeconomic indicators, including a median household income ≥$85,081 (22.5% vs. 17.1%, p=0.007) and median home value ≥$348,000 (33.7% vs. 25.1%, p<0.001). Additionally, a greater proportion of participants lived ≤4.0 miles from the nearest emergency department (79.6% vs. 72.4%, p=0.002). No significant sex differences were observed (63.7% vs. 63.8% male, p=0.968).
CONCLUSIONS: Clinical trial participation among Medicare beneficiaries with HCC remains low, with disparities driven by demographic and socioeconomic factors. These findings emphasize the need for improved enrollment strategies to increase access to emerging therapies.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HPR2
Topic
Health Policy & Regulatory
Topic Subcategory
Health Disparities & Equity
Disease
SDC: Oncology