Clinical Research in Community Oncology: Advancing Cancer Care Through Localized Clinical Trials

Recent FDA regulatory actions have highlighted concerns when global pivotal trials enroll a limited US population for a proposed US indication. 4 As more registrational programs adopt global development strategies, community oncology-where most US patients receive carewill remain essential to evidence generation that is interpretable to US practice.Changes in information technology-including widespread electronic health record (EHR) adoption, routine next-generation sequencing (NGS), electronic data capture, remote monitoring, and telehealth-have materially reshaped how community practices identify patients for trials, document protocol procedures, and manage research workflows.Further expansion of decentralized trial elements (eConsent, local laboratory and imaging use, direct-to-patient shipment where appropriate), interoperability across data sources, and responsible use of artificial intelligence (AI) for documentation and trial matching are likely to continue lowering barriers to participation while increasing expectations for data quality and audit readiness.In this article, we explore the significance, operational considerations, and business context of clinical research in community oncology and provide the perspective of the Sarah Cannon Research Institute (SCRI) on deploying early-phase and late-phase clinical research in community oncology practices in the United States. CONSOLIDATION OF COMMUNITY ONCOLOGY AND IMPLICATIONS FOR RESEARCHCommunity oncology has experienced substantial consolidation over the past decade.Traditional private practice is now largely divided into two broad organizational models: (1) practices that are in a management relationship with a large network and (2) practices that are in an employment relationship with either a university-based academic medical center (AMC) or a hospital health system.In the management-network model-sometimes referred to as "buy and bill" with respect to infusion services-examples include US Oncology (USON), OneOncology, and the American Oncology Network.By contrast, practices employed through health systems or AMCs frequently operate under 340B reimbursement structures and conduct clinical research through their parent organization (or affiliated university) with centralized governance and contracting.