The Oncology Center of Excellence (OCE) advances regulatory science, research, and policy to improve outcomes for people with cancer through cross-center coordination, stakeholder engagement, and applied research.
The Cancer in Older Adults Program focuses on improving outcomes for older adults with cancer by promoting research and clinical engagement tailored to this population.
The OCE Cardio-Oncology Program works to protect and promote cardiovascular health in patients and survivors of cancer.
The Immuno-Oncology Therapeutics Program coordinates FDA expertise to support development of therapies that harness the immune system for more effective cancer treatments.
The OCE Scientific Collaborative supports FDA oncology staff participation in applied regulatory science research and external collaborations.
The Oncology Artificial Intelligence Program advances understanding and application of artificial intelligence in oncology drug development.
The Oncology Cell and Gene Therapy Program concentrates on clinical evaluation and expedited development of transformative cell and gene therapies with curative potential.
The Oncology Labeling Program advances clinically meaningful, data-driven, and scientifically accurate drug information for healthcare professionals and patients with cancer through a cross-center approach.
The Oncology Real World Evidence Program promotes modernization of evidence development, supporting appropriate, fit-for-purpose use of real-world data to generate real-world evidence for regulatory decisions.
Oncology Regulatory Affairs enhances cross-center coordination of clinical review for oncology products.
The Patient-Focused Drug Development Program fosters collaboration between FDA centers and external stakeholders on patient outcomes research in cancer populations.
The Pediatric Oncology Program supports development of safe and effective drugs and biologics to treat cancer in children.
The Precision Oncology Program coordinates efforts across centers to accelerate regulatory science and new methodologies that deliver precision therapies, diagnostics, and biologics.
The Rare Cancers Program promotes development of safe and effective drugs and biologics for patients with rare cancers.
Project 5 in 5 crowdsources five clinically relevant questions to inform five pragmatic trials.
Project Asha is a collaboration to expand access to cancer clinical trials in India.
Project Catalyst provides guidance and educational resources to support development of directed and novel cancer therapies, focusing on small companies and academic incubators.
Project Confirm promotes transparency around outcomes related to accelerated approval for oncology indications.
Project Endpoint advances the development and use of clinical endpoints in oncology drug development.
Project Facilitate serves as a single point of contact to assist oncology healthcare providers and regulatory professionals with Expanded Access requests for individual patients.
Project FrontRunner encourages sponsors to consider optimal line-of-treatment settings, including earlier clinical settings, during drug development.
Project Livin’ Label is an educational initiative to improve understanding of oncology product labeling and awareness of recent FDA oncology approvals.
Project Optimus aims to reform dose optimization and dose selection paradigms in oncology drug development.
Project Orbis provides a framework for concurrent submission and review of oncology products with international regulatory partners.
Project Patient Voice is an online platform for patients, caregivers, and clinicians to review patient-reported symptom data from cancer clinical trials.
Project Point/Counterpoint produces a combined briefing document that presents both company and FDA positions for Oncologic Drugs Advisory Committee reviews.
Project Pragmatica seeks to increase efficiency and patient centricity by integrating pragmatic design elements that align clinical trials with routine clinical practice.
Project Renewal updates prescribing information for older oncology drugs to ensure labeling is clinically meaningful and scientifically current.
Project Significant (Statistics in Cancer Trials) promotes collaboration among stakeholders to improve design and analysis of cancer clinical trials.
Project Socrates provides educational opportunities for fellows, scientists, junior faculty, and others interested in regulatory science and drug development.
More information is available on the FDA website.
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