Can Real-World Evidence Close the Clinical Trial Gap?

The full article for this interview is available on Oncology Data Advisor. Check it out here: https://bit.ly/48PRtJo Every oncologist knows the moment: you’re discussing guideline-based options with a patient—and realize they wouldn’t have qualified for the pivotal trial behind the recommendation. In this episode of Oncology Unfiltered, Melissa Cutrona, MS, Co-Founder and General Manager of i3 Health and Oncology Data Advisor, sits down with Matthew Hadfield, DO, Oncology Data Advisor Editor in Chief, to examine one of oncology’s most persistent challenges: the widening gap between curated clinical trial populations and complex real-world patients. Dr. Hadfield breaks down why eligibility criteria often select for the “healthiest” oncology patients, how some criteria may be rooted in older chemotherapy-era assumptions, and what it means when guidelines meet patients with comorbidities, organ transplants, or other factors that excluded them from landmark studies. The conversation also explores the evolving role of phase 1 trials, why earlier trial enrollment is becoming more common, and how disparities in access and representation continue to shape who benefits from trial-driven advances. Finally, they discuss how real-world evidence—case series, retrospective studies, and institutional experience—can help clinicians fill the gaps when gold-standard randomized data doesn’t exist for the patient in front of them.