? Clinical and Translational Research Program (CR) The objective of the Clinical and Translational Research Program (CR) is to organize and support human studies conducted by UNC Lineberger faculty. Twenty years ago, with the growth of the research-active clinical faculty in medical, surgical, radiation, pediatric, and gynecologic oncology, UNC Lineberger made the decision to perform clinical studies through a Cancer Center CR Program. The clinical research faculty in oncology was built over this time as the Center played a key role in the recruitment of every UNC oncologist, selecting physicians with clinical science training and providing all of the startup and infrastructure for their research. This and the physical proximity to translational scientists (given that the Lineberger building serves as a virtual bridge between the Cancer Hospital, the Physicians' Office Building, and the basic and public health sciences) engenders collaborative research across our clinical disease-specific groups. While several clinician-scientists are appointed or co-appointed in basic or population science programs, the non-breast cancer clinical trials and human correlative science efforts are concentrated in CR. During the past five years, the program has incorporated outstanding faculty in drug development, statistical trial design and novel imaging modalities. The latter has and will continue to grow because of LCCC recruitment, a recent $20M investment in imaging instrumentation, and the opening of 3 new floors for imaging research in Marsico Hall. Since the prior funding cycle, the program has two new co- leaders, Claire Dees and Neil Hayes, exceptional clinician-scientists with complementary research skills. CR's national stature is illustrated by recent success in obtaining an NCI National Clinical Trials Network (NCTN) Lead Academic Participating Site (LAPS) grant, a tri- cancer center UM1 award establishing UNC within the Experimental Therapeutics Clinical Trials Network (ETCTN, with Dees as UNC PI), and one of 5 NCTN Integrated Technology Science Center (ITSC) grants (with Hayes as PI). CR has two overarching themes: Novel Therapies / Approaches and Tissue-Based Research. Highlights of program members' research over the past five years include leadership in many high- impact TCGA analyses, initiation of LCCC1108, Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions (NCT01457196)?, also called UNCseq?, which has enrolled over 1,000 patients over the past 2 years. In 2014 LCCC had 198 open therapeutic trials including 124 early phase trials, 24 of which are investigator-initiated trials (IITs). In 2014, 1731 UNC patients were accrued to interventional trials including 604 to treatment trials, many featuring innovative, correlative science relying on UNC Lineberger expertise in genomics, proteomics and drug delivery. The addition of affiliate sites raises the totals to 1990 all interventional and 720 treatment accruals. Over the past 5 years LCCC investigators have completed 215 early phase clinical trials, including 28 IITs, in addition to a number of consortia and cooperative group studies. CR has 64 members from 14 departments and had >1,500 publications over the prior funding period (36% collaborative). In 2014, our program members held 179 grants and $25.2M (total cost) in annual extramural funding, including 31 grants and $8.4M (total costs) from the NCI. A growing emphasis on immunotherapy stimulated by faculty recruitment and GMP facility construction are key future directions.
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