List of OCE Programs and Projects

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The Oncology Center of Excellence (OCE) runs programs and projects to improve cancer prevention, treatment, and regulatory science through research, collaboration, and stakeholder engagement.

Cancer in Older Adults Program works to improve outcomes for older adults with cancer through targeted research and engagement.

Cardio-Oncology Program promotes cardiovascular health among cancer patients and survivors by integrating cardiac risk assessment and management into oncology care.

Immuno-Oncology Therapeutics Program coordinates FDA expertise to support development of therapies that harness the immune system for more effective cancer treatment.

OCE Scientific Collaborative supports FDA oncology staff participating in applied regulatory science research and external collaborations.

Oncology Artificial Intelligence Program advances the understanding and application of artificial intelligence in oncology drug development.

Oncology Cell and Gene Therapy Program focuses on clinical evaluation and expedited development of transformative cell and gene therapies with curative potential.

Oncology Labeling Program develops clinically meaningful, data-driven, and scientifically accurate drug labeling for clinicians and patients.

Oncology Real World Evidence Program modernizes evidence development through scientific collaboration and policy to advance appropriate use of real-world data for regulatory decisions.

Oncology Regulatory Affairs enhances cross-center coordination of clinical review for oncology products.

Patient-Focused Drug Development Program fosters collaboration between FDA centers and external stakeholders engaged in patient outcomes research in cancer populations.

Pediatric Oncology Program promotes the development of safe and effective drugs and biologics to treat cancer in children.

Precision Oncology Program coordinates efforts across centers to catalyze regulatory science and apply new methodologies that advance precision medicine in oncology.

Rare Cancers Program supports 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 clinical trials.

Project Asha is a collaboration to increase access to cancer clinical trials in India.

Project Catalyst provides guidance and educational resources to support anticancer therapy development, focusing on small companies and academic incubators.

Project Confirm promotes transparency of outcomes related to accelerated approval for oncology indications.

Project Endpoint advances the selection and use of endpoints in oncology drug development.

Project Facilitate serves as a single point of contact and information center to help providers and regulatory professionals submit Expanded Access Requests for individual patients.

Project FrontRunner encourages sponsors to consider the most appropriate line-of-treatment setting, including earlier clinical settings.

Project Livin’ Label is an educational initiative to improve understanding of oncology product labels and increase awareness of recent FDA oncology approvals.

Project Optimus reforms dose-optimization and dose-selection practices in oncology drug development.

Project Orbis provides a framework for concurrent submission and review of oncology products among international regulatory partners.

Project Patient Voice offers an online platform displaying patient-reported symptom data from cancer clinical trials for patients, caregivers, and providers.

Project Point/Counterpoint produces a combined Oncologic Drugs Advisory Committee briefing document presenting both company and FDA positions in a single resource.

Project Pragmatica introduces pragmatic design elements to integrate clinical trials with real-world practice, enhancing efficiency and patient centricity.

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 stakeholder collaboration to advance the design and analysis of cancer clinical trials.

Project Socrates provides educational opportunities for hematology/oncology fellows, scientists, junior faculty, and others interested in regulatory science and drug development.