Core C - Clinical Trials

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Project Summary/Abstract - Core C: Core C will provide experienced, well-trained clinical trials staff specializing in implementing translational, clinical research involving pharmacological ascorbate (P-AscH-). This group of clinical researchers has been doing clinical trials for the past 10 years and has initiated as well as completed phase 1 and 2 trials using P-AscH- combined with radiation and/or chemotherapy in pancreas, lung, and GBM subjects. Core C will initiate, conduct, and complete all aspects of complex human subjects research with P-AscH- which are proposed in Projects 1 and 2. Core C will also interface with Core B for patient sample acquisition and processing, for biomarker evaluation as well as establishing a structured training program for staff participating in each clinical trial research effort. This training program will include instruction in how to review processes for eligibility determination as well as the review of ascorbate therapy infusions (including administration, review of and contraindications) and adverse event reporting. In addition, Core C will provide expert guidance and resources as well as interface with the Holden Comprehensive Cancer Center clinical trials infrastructure [(i.e., Protocol Review & Monitoring Committee (PRMC)/ Data and Safety Monitoring Committee (DSMC)] to identify and report all key research data, and to design electronic case report forms for complete data capture, and to ensure data veracity for ultimate result reporting to the FDA, and as well as in the preparation of peer- reviewed publications.