Leveraging Real-World Data And AI To Broaden Patient Diversity In Oncology Clinical Trials

By Anosheh Afghahi, MD, MPH, Medical Director, Flatiron Health

The integration of Electronic Health Records (EHR) and Electronic Data Capture (EDC) systems is pivotal in enhancing clinical trial diversity, as emphasized by the FDA's draft guidance on Diversity Action Plans (DAPs). This guidance encourages the inclusion of historically underrepresented populations in clinical research, aiming to generate more representative data for medical products. Technological advancements, particularly in artificial intelligence and real-world data (RWD), have revolutionized trial methodologies by streamlining patient recruitment and data analysis. Flatiron Health exemplifies this integration by leveraging extensive EHR data to improve oncology trial designs, focusing on community involvement and accessibility for underserved populations. A recent analysis of a nationwide de-identified EHR database revealed that broadening trial eligibility criteria significantly increased the inclusion of diverse cancer patients, particularly benefiting older, female, and non-Latinx Black individuals. The confluence of EHR, EDC systems, and diversity initiatives presents a transformative opportunity to advance medical research and enhance patient outcomes, ensuring that new interventions are effective across varied demographic groups.