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OCE Scientific Collaborative

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The Oncology Center of Excellence (OCE) Scientific Collaborative was initiated in 2019 to promote regulatory science research in oncology. Conduct of regulatory science research in oncology is critical to FDA’s mission to protect the public health by ensuring the safety, efficacy, and security of human drugs, biological products, and medical devices. FDA oncology staff participate in both intramural and extramural research projects to address specific challenges encountered during regulatory review processes.

Learn more about the OCE Scientific Collaborative

The OCE has identified nine scientific interest areas and one cross cutting area for its applied research efforts. Visit OCE Scientific Interest Areas for more information.

The OCE has a rigorous extramural research program and engages with external scientists through several approaches including informal collaborations, research collaboration agreements (see selected currently active Oncology RWE Collaborations), memoranda of understanding, and public private partnerships (see example from Project Catalyst). The OCE has also identified external research collaborators through novel mechanisms such as crowdsourcing. 

OCE uses several mechanisms to fund extramural research:

For more information about oncology extramural projects, visit OCE-Funded Active Extramural Research Projects.

For information on submitting an oncology-related application to the FDA BAA, please review OCE BAA Frequently Asked Questions. 

OCE conducts a variety of intramural research projects. FDA has access to a large amount of data from regulatory submissions, which provides a unique opportunity to answer clinically important research questions, including evaluation of clinical trial representation, regulatory endpoints, safety signals, dosage optimization, and other drug development issues. Furthermore, OCE researchers work in collaboration with several OCE programs, including the Oncology Real World Evidence Program, the Oncology Translational Research lab, and other experts across FDA to answer important regulatory questions.

OCE Research Publications

For more information about OCE publications from extramural and intramural research projects, visit OCE Publications.

Publications about the OCE Scientific Collaborative

For questions regarding the OCE Scientific Collaborative, contact FDAOncology@fda.hhs.gov.

Further Information

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