The Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration coordinates programs and projects to improve cancer prevention, diagnosis, treatment and survivorship through regulatory science, research, and stakeholder engagement.
OCE programs address clinical needs across populations and technologies. The Cancer in Older Adults Program focuses on improving outcomes for older people with cancer. The Pediatric and Rare Cancers programs promote development of safe and effective therapies for children and patients with uncommon malignancies. The Cardio-Oncology Program works to protect cardiovascular health in cancer patients and survivors. The Patient-Focused Drug Development Program fosters collaboration on patient outcomes research and ensures patient perspectives inform regulatory decisions.
Programs that advance scientific and regulatory approaches include the Precision Oncology Program, which integrates efforts to apply new methodologies for targeted drugs, diagnostics, and biologics; the Immuno-oncology Therapeutics Program, which supports development of immune-based cancer treatments; and the Oncology Cell and Gene Therapy Program, which focuses on accelerating transformative, potentially curative technologies. The Oncology Artificial Intelligence Program explores the application of AI in oncology drug development. The Oncology Labeling Program and Oncology Regulatory Affairs provide cross-center approaches to ensure clinically meaningful, data-driven drug information and more coordinated clinical reviews. The Oncology Real World Evidence Program advances the appropriate use of real-world data and real-world evidence for regulatory purposes. The OCE Scientific Collaborative supports staff participation in applied regulatory science research.
OCE projects target trial design, access, transparency and education. Project 5 in 5 crowdsources clinically relevant questions for pragmatic trials. Project Asha expands clinical trial access in India. Project Catalyst offers guidance and resources to support development of novel anticancer therapies, especially for small companies and academic incubators. Project Facilitate serves as a single-point contact to help clinicians and regulatory professionals submit Expanded Access requests for individual patients. Project Orbis enables concurrent international submission and review of oncology products. Project FrontRunner encourages companies to consider earlier treatment settings during development.
Initiatives focused on evidence, endpoints and labeling include Project Confirm, which promotes transparency around outcomes tied to accelerated approvals; Project Endpoint, which advances the use of clinical endpoints in oncology drug development; Project Optimus, which reforms dose optimization and selection; Project Renewal, which updates prescribing information for older oncology drugs; and the Livin’ Label educational initiative to increase understanding of product labels and recent approvals. Project Patient Voice provides an online platform for viewing patient-reported symptom data from clinical trials. Project Point/Counterpoint integrates company and FDA positions in a single advisory committee briefing document. Project Pragmatica seeks to increase efficiency and patient centricity by integrating pragmatic elements into trials. Project Significant (Statistics in Cancer Trials) promotes collaboration on trial design and analysis. Project Socrates offers educational opportunities for fellows, scientists and junior faculty interested in regulatory science and drug development.
These coordinated programs and projects advance regulatory science, expand clinical trial access, and work to improve outcomes for people affected by cancer.
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