Bridging Equity in U.S. Oncology Research: A Systematic Review of Real-World Data (RWD) Applications and Emerging Strategies to Support Clinical-Trial Participation

Background: Many patients from racial, ethnic, and lower-income backgrounds, as well as those living in rural areas, continue to be underrepresented in oncology clinical trials. This lack of diversity affects the generalizability of trial findings and contributes to inequitable access to emerging cancer therapies. RWD gathered from sources like electronic health records, cancer registries, decentralized trials, and community outreach programs, has been increasingly considered as a practical tool for identifying gaps and guiding potential strategies to improve participation. Objective: This review examines how RWD is currently being used in U.S. oncology research and highlights emerging strategies that may support more equitable trial participation. It also describes the current landscape of practice and the potential pathways through which RWD might be leveraged to strengthen equitable trial access. Methods: A search of major medical databases and policy sources was conducted on November 24, 2025. Studies published between 2010 and 2025 were included if they used RWD to identify participation gaps or to implement interventions affecting enrollment, retention, or access. Given the heterogeneity in study design and outcomes, the findings were summarized descriptively. Results: Fifty-one studies were included. Six main strategies emerged: tracking disparities to guide site selection, updating eligibility rules, decentralized or hybrid trial designs, community engagement with patient navigation, AI-driven matching tools, and using RWD to support retention. Programs that focused on community engagement and navigation demonstrated the most consistent improvements. Key barriers included incomplete demographic data, fragmented datasets, privacy issues, and limited prospective evaluation. Conclusions: With strong community involvement and careful governance, RWD support efforts to make oncology trials more inclusive. Future efforts should focus on standardizing demographic data, evaluating RWD-based recruitment strategies in practice, and fostering collaboration among stakeholders.