Clinical Research (03)

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CLINICAL RESEARCH PROGRAM Project Summary The major goal of the Clinical Research Program (CRP) of the Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) is to serve as a hypothesis-driven incubator and catalyst for the clinical translation of novel therapeutic, diagnostic, and supportive care strategies. The goal of the CRP will be achieved through the following Specific Aims: (1) Translate advances in the understanding of cancer from the WFBCCC's basic sciences and population science Programs into novel therapeutic strategies with correlative biomarkers of response; (2) Promote the development and conduct of innovative clinical trials for rare or difficult to treat cancers and sites of metastasis; and (3) Enhance understanding in cancer-related symptom science, including leveraging the Wake Forest National Cancer Institute Community Oncology Program Research Base (WF NCORP RB; PI: Glenn Lesser, M.D.). CRP research is comprised of two themes within these aims: experimental therapeutics and addressing health disparities, with particular focus on cancers of high incidence in the WFBCCC catchment area. CRP is led by William Blackstock, M.D., with Dr. Lesser appointed as Program Co-Leader in August of 2015. The Program has 43 members from 17 different departments. Program members have $4.5M in peer-reviewed extramural funding (excluding training grants) of which 58.7% is from the NCI. Among the members' 513 publications, 23% were intra-programmatic, 14% were inter-programmatic, and 63% were inter-institutional during the 11/01/10 – 10/31/15 reporting period. The CRP has benefited from the ability to use the WF NCORP RB network as a platform for community-based clinical trials; in turn, the WF NCORP RB can translate the expertise of the CRP's clinician-scientists, strengthening each of these NCI- supported entities. Twelve Disease-Oriented Teams (DOTs) have been formalized within the WFBCCC research infrastructure to further enhance translation of WFBCCC science. Each DOT has a specific focus: brain, breast, geriatrics, gastrointestinal, genitourinary, gynecologic, head and neck, hematologic, lung, melanoma, pediatrics, and sarcoma. DOTs are comprised of basic scientists, population scientists, and clinicians, and serve as vehicles for robust interprogrammatic interactions leading to more innovative and comprehensive research portfolios. During the Data Table 3 reporting period of 07/01/14-06/30/15, 268 trials were open and 2,875 patients were accrued. Sixty-three percent of the trials were treatment trials, 15% were non-treatment interventions, and 21% were non-interventional studies. Twelve percent of treatment trials were investigator-initiated.