Advancing Real-World Data to Generate Regulatory Grade Real-World Evidence in Oncology

On February 20, Friends of Cancer Research, Duke-Margolis Institute for Health Policy, Reagan-Udall Foundation for the FDA, and Aetion co-hosted "Advancing Real-World Data to Generate Regulatory Grade Real-World Evidence in Oncology." This collaborative workshop convened a wide array of stakeholders, including regulatory experts, academia, clinicians, patients, advocates, data vendors, and biopharma representatives. The event discussed and identified pressing gaps in real-world data (RWD) collection and accessibility and dove into the importance of ensuring that real-world evidence (RWE) generation is relevant to patient care.
Throughout the sessions, participants delved into the U.S. regulatory framework for RWD/RWE and discussed strategies to overcome challenges in data quality, accessibility, and patient care applicability. Sessions throughout the day discussed recent advancements in the field and identified opportunities for improving evidence generation in oncology that could positively impact patients’ lives. The workshop concluded with an open conversation on remaining challenges and next steps for industry stakeholders. This workshop marks a crucial step forward in optimizing the use of RWD and RWE to improve oncology patient care and treatment, reflecting a broad commitment across the sector to drive meaningful progress.