The Price of Progress: Cost Considerations in Hepatocellular Carcinoma Clinical Trials

Hepatocellular carcinoma (HCC) imposes a substantial global health and economic burden, with treatment costs exceeding $154,688 per patient in the United States. Despite the growing emphasis on value-based oncology, the inclusion of cost outcomes in HCC clinical trials remains poorly characterized. This study aimed to quantify the prevalence and characteristics of cost-related end points in HCC trials and assess trends in economic evaluation across study designs and geographic regions.

ClinicalTrials.gov was queried using the terms "hepatocellular carcinoma" and "cost." Trials were included if cost was identified as a primary, secondary, or exploratory outcome. Trial characteristics, design, phase, sample size, intervention type, and country of origin were extracted and analyzed descriptively.

Of 3685 HCC clinical trials identified, only 53 (1.4%) included cost as any outcome. Among these, 10 (18.8%) designated cost as a primary end point, 35 (66%) as secondary, and 8 (15.1%) as exploratory. Most cost-inclusive trials were interventional (73.6%), commonly involving radiation therapy (35.9%) or chemotherapy (20.5%). The United States (34%) and China (22.6%) accounted for the majority of cost-focused studies. The median enrollment was 180 participants, although 30.2% of trials had fewer than 100 participants.

Cost end points remain underrepresented in HCC clinical research, despite the high economic burden and proliferation of costly systemic therapies. Integrating prospective economic evaluation into trial design is essential for value-based cancer care, enabling stakeholders to align therapeutic innovation with affordability, sustainability, and equitable patient access.