All Times EDT
Keywords: RTOR, Regulatory Initiatives, FDA Oncology Center of Excellence
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence launched the Real-Time Oncology Review (RTOR) pilot program in 2018, aiming to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible. RTOR allows the FDA to review much of the data earlier, after the database lock and clinical trial results become available, before the information is formally submitted to the FDA. Drugs likely to demonstrate substantial improvements over available therapy, straight-forward study designs and easily interpretable endpoints are major considerations for a drug to be selected for RTOR. The goal for this session is for attendees to discuss the challenges during the RTOR process, how statisticians could prepare proactively to address the questions or requests that’s due within a restricted timeline.