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  1. Oncology Center of Excellence

OCE Publications

Journal publications by FDA oncology/hematology reviewers

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OCE Publications

FDA's Oncology Center of Excellence publishes numerous articles in peer-reviewed scientific journals, including original research papers, drug approval summaries, and regulatory perspectives.

Intramural research papers largely involve analysis of clinical trial data submitted with marketing applications. Such analyses have been particularly helpful to evaluate novel endpoints, including measures of surrogacy, and investigate safety concerns across trials. Other intramural research papers are produced by OCE’s Project NextGen, which leverages the expertise of the Oncology Translational Research Laboratory.

Extramural research papers address a wide variety of topics, including the scientific interest areas identified by the OCE Scientific Collaborative. These papers are typically produced through funded and unfunded (see Selected Currently Active Oncology RWE Collaborations) research. Extramural research projects may involve prospective or retrospective data analysis, as well as laboratory-based studies.

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