OCE Programs
Cancer in Older Adults Program works to improve outcomes for older adults with cancer through targeted engagement and research.
OCE Cardio-Oncology Program promotes cardiovascular health among cancer patients and survivors.
Immuno-oncology Therapeutics Program coordinates FDA expertise to support development of therapies that harness the immune system for cancer treatment.
OCE Scientific Collaborative supports FDA oncology staff participating in applied regulatory science research and collaborations with external experts.
Oncology Artificial Intelligence Program advances understanding and application of AI in oncology drug development.
Oncology Cell and Gene Therapy Program focuses on clinical evaluation and expedited development of transformative cell- and gene-based cancer therapies.
Oncology Labeling Program provides a cross-center approach to produce clinically meaningful, data-driven, and scientifically accurate drug information for clinicians and patients.
Oncology Real World Evidence Program advances modernization of evidence development through scientific collaboration and policy work to promote appropriate use of real-world data for regulatory purposes.
Oncology Regulatory Affairs enhances cross-center coordination of oncology product clinical review.
Patient-Focused Drug Development Program fosters collaboration between FDA centers and external stakeholders on patient outcomes research in cancer populations.
Pediatric Oncology Program promotes 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 support precision drugs, diagnostics, and biologics.
Rare Cancers Program supports development of safe and effective drugs and biologics for patients with rare cancers.
OCE Projects
Project 5 in 5 crowdsources five clinically relevant questions for five pragmatic trials.
Project Asha is a collaboration to increase cancer clinical trial access in India.
Project Catalyst offers guidance and educational resources to support informed 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 use and understanding of clinical endpoints in oncology drug development.
Project Facilitate provides a single point of contact to help oncology healthcare providers and regulatory professionals submit Expanded Access Requests for individual patients.
Project FrontRunner encourages drug developers to consider appropriate lines of treatment, including earlier clinical settings.
Project Livin’ Label is an educational initiative to improve understanding of oncology product labels and awareness of recent FDA oncology approvals.
Project Optimus reforms dose optimization and selection paradigms in oncology drug development.
Project Orbis offers a framework for concurrent submission and review of oncology products among international partners.
Project Patient Voice is an online platform displaying patient-reported symptom data collected from cancer clinical trials.
Project Point/Counterpoint produces an Oncologic Drugs Advisory Committee briefing document that presents both company and FDA positions in a single file.
Project Pragmatica integrates pragmatic design elements to increase trial efficiencies and patient centricity by aligning clinical trials more closely with routine clinical practice.
Project Renewal updates prescribing information for certain older oncology drugs to ensure labeling is clinically meaningful and scientifically current.
Project Significant (Statistics in Cancer Trials) promotes stakeholder collaboration 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.
Further information is available from the FDA’s Oncology Center of Excellence.
Leave a Reply