USING safety-net hospitals to enroll patients with solid tumor could make Phase I trials more representative of real-world patient populations, according to an analysis by a comprehensive cancer center.
Clinical trial recruitment is particularly challenging for Phase I solid tumor trials. At that stage, eligibility criteria are often restrictive, and physicians have little or no evidence of how a molecule will perform in humans. The shortfall of clinical safety and tolerability data forces sponsors to initially test low doses that may expose patients to risks without improving health outcomes.
Geography is another barrier to enrollment. With Phase I trials often enrolling at academic centers, many patients live too far from the study site to make participation practical. Enrolling patients at safety-net hospitals, which provide care for Medicaid beneficiaries and people who are uninsured, could help tackle the challenges.
Two-site Strategy Shows Promise
The University of Southern California (USC) Norris Comprehensive Cancer Center, USA, enrolled patients at its private and safety-net hospitals. Physicians analyzed the impact of the strategy by reviewing data on 611 patients who enrolled in USC Norris studies from 2015–2022.
The analysis showed that 43.2% of the patients were non-Hispanic White. Hispanic, White, and Asian were the two next biggest enrollment demographics, accounting for 26.2% and 20.6%, respectively, of the total. Almost 4% of patients were non-Hispanic Black. The authors said racial/ethnic diversity was above historical national averages in the United States.
Patient outcomes were similar regardless of enrollment site, the researchers said. Median overall survival was 6.5 months, and median progression-free survival was 2.3 months. The overall response rate was 7.4%, including a 1% complete response rate. Another 36.8% of patients had stable disease. At 44.5%, disease progression was the most common response.
Validating the Strategy’s Viability
The authors said the data and experience of recruiting patients from 2015–2022 show it is feasible to enroll solid tumor studies at a private hospital setting and in a safety net hospital. That knowledge, paired with the health outcomes and diversity data, could support the inclusion of both hospital types in Phase I enrollment strategies.
Reference: Thomas JS et al. Outcomes of patients with solid tumor treated on phase i clinical trials within a comprehensive cancer center’s private and safety-net hospitals. JCO Oncol Pract. 2025 Dec 3:OP2500542.
Author
Emily Hayes, Freelance Writer and Editor
