Administrative, Statistical, and Regulatory

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The Biostatistics component of the Administrative-Biostatistics Core 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. Biostatistics will support all three 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. For the clinical trials that are planned in Project 1 and Project 3, we will collaborate with basic scientists and clinicians on finalizing the development of protocols that are methodologically sound, and that will pass scientific, ethical, and regulatory review. We will perform interim analyses of safety for the clinical trials, and final analyses of their data on safety, immune response, and treatment efficacy. We will work with the project investigators, UPCI Informatics, and with UPCI Clinical Research Services 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.