Building HOPE: operationalizing hybrid decentralized oncology clinical trials with community providers beyond...

Cancer clinical trials are essential to high-quality oncology care, yet regulatory and logistical barriers have concentrated trial activity at academic medical centers, limiting access for rural and underserved populations. In 2022, 75% of U.S. counties had no active cancer treatment trials. North Carolina (NC) exemplifies these disparities, where limited local trial options, long travel distances, and socioeconomic barriers hinder participation.

To develop operational methodologies for hybrid decentralized clinical trials (hDCTs), the University of North Carolina Lineberger Comprehensive Cancer Center (LCCC) conducted an engagement initiative across nine community hospitals in NC without formal contractual research network agreements. 120 stakeholders-healthcare providers (HCPs), nurses, pharmacists, administrators, and advocates-shared insights that informed the co-development of adaptable workflows, including communication protocols, adverse event management strategies, and literacy-sensitive patient materials. Procedures were designed to align with local clinical practices and reduce burden on HCPs without requiring engagement from a regulatory standpoint.

Visits revealed critical local resources, such as patient transportation, culturally tailored educational materials, and advocacy, that could facilitate hDCT participation. Key facilitators included motivated local champions, supportive leadership, and infrastructure for remote visits. Within 3 months, seven of nine locations initiated hDCT planning, five began patient referrals, and two enrolled patients. Early data show promising uptake and strong institutional commitment.

hDCTs are feasible in community settings beyond traditional healthcare networks and can expand trial access by reducing logistical and financial burdens. The LCCC model offers a scalable framework to promote equity in cancer research.