OBJECTIVES: This study assessed the demographic and clinical factors associated with hepatocellular carcinoma (HCC) patients participating in clinical trials.

METHODS: This retrospective database analysis was conducted using the Premier PINC AI™ Healthcare Database. Patients were included if they had an encounter for HCC between 01/01/2016 and 12/31/2022, identified by the International Classification of Diseases, Tenth Revision (ICD-10) diagnosis code for liver cell carcinoma (C22.0). Patients were stratified based on their participation in clinical trials, identified by the presence of ICD-10 diagnosis code Z00.6 (encounter for examination for normal comparison and control in clinical research program).

RESULTS: Overall, 105,348 HCC patients were identified, the majority of whom were male (72.5%), White (70.6%), and non-Hispanic (69.9%). The mean age was 65.5, the mean Charlson comorbidity index (CCI) score was 6.56, and 48.0% of patients were located in the Southern region of the United States. Among this cohort, 904 (0.9%) patients participated in clinical trials. Compared to non-participants, clinical trial participants were significantly older (mean age: 67.0 vs. 65.5, p<0.0001), had a higher mean CCI (8.10 vs. 6.54, p<0.0001), and were more likely to be located in an urban area (95.7% vs. 90.0%, p<0.0001). Census region was significantly associated with clinical trial participation, with a higher proportion of clinical trial participants located in either the Midwest (23.6% vs. 18.1%, p<0.0001) or the Northeast (20.0% vs.16.4%, p=0.002) compared to non-participants. However, there was no significant difference in race (White: 73.2% vs. 70.6%, p>0.05) or sex (male: 70.6% vs. 72.5%, p>0.05) between trial participants and non-participants.

CONCLUSIONS: This study highlights a low clinical trial participation rate (0.9%) and geographical underrepresentation of the HCC population in clinical trials. Further investigations into the specific factors influencing trial participation are warranted to develop targeted interventions aimed at enhancing clinical trial engagement.