CORE C (Biostatistics) will reside within the University of Pittsburgh Cancer Institute's (UPCI) Biostatistics Facility, which provides clinical and basic-science investigators in UPCI with statistical expertise in design, analysis, and reporting of cancer-related research studies. These cover basic-science studies;phase I and phase II oncology clinical trials;epidemiologic studies, including those related to cancer prevention and awareness;and investigations of behavioral and health sequelae of cancer treatment. In its role as Core C for this Program Project, the Biostatistics Core will support all five research projects. We will collaborate with investigators on statistical aspects of the design of in vitro and in vivo laboratory-based studies as new data come to light, and perform both exploratory and confirmatory statistical analyses of the resulting data from key experiments in Projects 1 - 5. For the clinical trial that is planned (Project 4), we will collaborate with basic scientists and clinicians on further developing and finalizing a protocol that is methodologically sound, and that will pass scientific, ethical, and regulatory review. We will perform interim analyses of safety for the SPORE's clinical trials (Projects 2, 3 &4), and final analyses of their data on safety, immune response, and treatment efficacy. We will contribute to the review of the SPORE's developmental research-program proposals, and provide statistical support to those that are funded. We will provide statistical support to the career-development awardees. We will work with the project investigators, with Core D (Informatics), and with UPCI Clinical Research Services, a component of Core A, to ensure that the requisite laboratory and clinical-trial data are available for statistical analyses. We will collaborate with the project investigators in writing and preparing progress reports, abstracts, manuscripts, and presentations.
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