List of OCE Programs and Projects

The Oncology Center of Excellence (OCE) oversees programs and projects to improve cancer treatment, regulatory science, and patient outcomes.

Cancer in Older Adults Program improves outcomes for older adults with cancer through engagement and research.

OCE Cardio-Oncology Program promotes cardiovascular health in cancer patients and survivors.

Immuno-oncology Therapeutics Program promotes development of immunotherapies that harness the immune system for more effective cancer treatment.

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

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 cell and gene therapies with curative potential.

Oncology Labeling Program develops clinically meaningful, data-driven drug labeling for healthcare practitioners and patients.

Oncology Real World Evidence Program modernizes evidence development to advance appropriate use of real-world data to generate real-world evidence for regulatory purposes.

Oncology Regulatory Affairs coordinates cross-center regulatory review of oncology products.

Patient-Focused Drug Development Program fosters collaboration on patient outcomes research across FDA centers and external stakeholders.

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

Precision Oncology Program coordinates cross-center efforts to advance regulatory science and methodologies for precision oncology, accelerating development of targeted drugs, diagnostics, and biologics.

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 for five pragmatic trials.

Project Asha expands cancer clinical trial access in India.

Project Catalyst provides guidance and resources to support anticancer therapy development, working primarily with small companies and academic incubators.

Project Confirm promotes transparency of outcomes following accelerated approval in oncology.

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

Project Facilitate serves as a single point of contact to assist healthcare providers and regulatory professionals with Expanded Access requests for individual cancer patients.

Project FrontRunner encourages developers to consider optimal line-of-therapy settings, including earlier-stage use.

Project Livin’ Label educates stakeholders about oncology product labeling and recent FDA approvals.

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

Project Orbis enables concurrent submission and review of oncology products with international partners.

Project Patient Voice provides patient-reported symptom data from cancer trials for patients, caregivers, and clinicians.

Project Point/Counterpoint combines company and FDA positions into a single Oncologic Drugs Advisory Committee (ODAC) briefing document.

Project Pragmatica integrates pragmatic design elements to align clinical trials with routine clinical practice and enhance patient centricity.

Project Renewal updates prescribing information for older oncology drugs to ensure labels are clinically meaningful and up to date.

Project Significant (Statistics in Cancer Trials) advances design and analysis of cancer trials through stakeholder collaboration on statistical methods.

Project Socrates offers educational opportunities on regulatory science and drug development for fellows, scientists, and junior faculty.

Further information is available from the FDA.