EARLY PHASE CLINICAL RESEARCH SUPPORT (Core 018)

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Abstract: Early Phase Clinical Research Support (EPCRS Early Phase Clinical Research Support (EPCRS) provides funding for dedicated clinical research nurse and data manager support for the coordination and implementation of innovative, proof-of-principle early phase clinical trials initiated by UPCI members. A major objective of the current project period was to continue to develop a robust Phase I clinical trials program that translates the strong science being conducted in the various UPCI research programs. Of note, the UPCI Phase I Team has worked closely with the UPCI CCSG disease-oriented programs, including Breast and Ovarian Cancer, Head and Neck Cancer, Lung Cancer, and Melanoma to prioritize, design, develop, and implement innovative phase I clinical trials with incorporation of important correlative science biomarkers. The specific aims of EPCRS are to: (1) Continue to expand UPCI’s phase I clinical trials portfolio through support of innovative, proof-of-principle cancer studies to evaluate new agents, medical procedures, and devices in order to provide the data necessary to apply for funding of later phase studies; (2) Stimulate new and collaborative early phase clinical trials across the UPCI research programs; and (3) Incorporate correlative pharmacodynamic biomarkers and imaging into early phase clinical trials. The UPCI Phase I Team is deeply committed to using a team science approach in the development of new investigational agents. This team science approach is best highlighted in the membership of the team, which has significantly grown since the 2010 CCSG review to now include expertise covering the entire range of experimental therapeutics, pre-clinical basic scientists, clinical investigators, translational scientists, clinical pharmacologists focused on pharmacokinetics (PK)/pharmacodynamics (PD), immunologists focused on immune monitoring, radiologists specializing in tumor assessment and development of imaging modalities, and statistical expertise in early-phase clinical trial design along with analytical methods to assess conventional clinical endpoints with sophisticated biomarker and molecular data. In addition, the Phase I Team has taken full advantage of the extensive experience of UPCI and the institution as it relates to tumor collection and tissue banking, and in the area of tumor characterization using sophisticated, state-of-the-art molecular diagnostics.