The Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration works to improve outcomes for people with cancer by coordinating regulatory science, research, and stakeholder engagement across FDA Centers.
OCE programs address a range of priorities. The Cancer in Older Adults Program focuses on improving outcomes for older patients through engagement and research. The Cardio-Oncology Program promotes cardiovascular health in cancer patients and survivors. The Immuno-oncology Therapeutics Program supports development of immune-based cancer treatments. The Scientific Collaborative supports FDA oncology staff participating in applied regulatory science research and external collaborations. The Oncology Artificial Intelligence Program advances understanding and application of AI in oncology drug development. The Cell and Gene Therapy Program concentrates on clinical evaluation and expedited development of transformative therapies. The Oncology Labeling Program works to produce clinically meaningful, data-driven drug information for clinicians and patients. The Real World Evidence Program advances appropriate use of real-world data for regulatory decision-making. Oncology Regulatory Affairs enhances cross-center coordination of clinical review. The Patient-Focused Drug Development Program fosters collaboration on patient outcomes research. The Pediatric Oncology Program supports development of safe and effective therapies for children. The Precision Oncology Program coordinates efforts to apply new methodologies for targeted drugs, diagnostics, and biologics. The Rare Cancers Program promotes development of therapies for patients with rare cancers.
OCE projects support practical improvements in oncology research and regulation. Project 5 in 5 crowdsources clinically relevant questions for pragmatic trials. Project Asha expands clinical trial access in India. Project Catalyst provides guidance and educational resources to support anticancer therapy development, especially for small companies and academic incubators. Project Confirm promotes transparency of outcomes tied to accelerated approval. Project Endpoint advances use of endpoints in oncology drug development. Project Facilitate serves as a single-point contact to help providers and regulatory professionals submit Expanded Access requests for individual patients. Project FrontRunner encourages consideration of optimal treatment-line settings during drug development. Project Livin’ Label is an educational initiative to increase understanding of oncology product labels and recent FDA approvals. Project Optimus reforms dose optimization and selection paradigms. Project Orbis enables concurrent submission and review of oncology products with international partners. Project Patient Voice provides an online platform to view patient-reported symptom data from cancer trials. Project Point/Counterpoint combines company and FDA positions into a single ODAC briefing document. Project Pragmatica integrates pragmatic trial design elements to enhance efficiency and patient centricity. Project Renewal updates prescribing information for older oncology drugs to ensure it is clinically meaningful and current. Project Significant advances statistical design and analysis in cancer trials. Project Socrates offers educational opportunities about regulatory science and drug development for trainees and early-career researchers.
Leave a Reply