EARLY PHASE CLINICAL RESEARCH SUPPORT (Core 020)

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Abstract - Early Phase Clinical Research Support (EPCRS) The Early Phase Clinical Research Support (EPCRS) provides critical resources for innovative short duration research protocols at UNC Lineberger Comprehensive Cancer Center (LCCC) in the form of skilled and specialized research coordinator, data management, and laboratory support. The trials supported by this resource are: complex with strong correlative science and/or pharmacokinetic and pharmacodynamic components; LCCC investigator-initiated; and primarily based on scientific expertise and interests of LCCC members. Trials are selected from among those submitted to the Protocol Office Executive Committee for review. Dr Claire Dees, EPCRS Faculty Director and co-leader, Clinical Research Program, in direct consultation with Drs. Carey (Associate Director, Clinical Sciences) and Hayes (co-leader, Clinical Research Program), makes the final selection. LCCC members conducted numerous innovative studies over the last five years including those: evaluating novel compounds with radiation; involving novel combinations; and incorporating novel correlative biomarkers and imaging. Many ECPRS supported trials originated in basic and preclinical science in UNC Lineberger laboratories. Since 2010, LCCC recruited a number of talented investigators actively growing our Phase I investigator initiated trial portfolio and so we anticipate expanded ECPRS use. In addition, the inaugural trials of the UNC immunotherapy center will begin in this cycle and will require additional specialized support. The first patients will be enrolled on UNC immunotherapy trials in the spring of 2016 and these initial trials would include patients with acute lymphoblastic leukemia, chronic lymphocytic leukemia, Hodgkin lymphoma, and multiple myeloma. The strong commitment of the UNC Lineberger leadership to the development of novel therapeutics as a Cancer Center strategic direction creates an environment that will generate even greater demand for specialized support.