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 SPORE, the Biostatistics Core will support all four 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 1-4. 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. We will also conduct methodological research motivated by the SPORE projects to improve the statistical efficiency in the study design and analysis.
Members of the biostatistics core have considerable statistical expertise and experiences in the design and analysis of both laboratory and clinical data. We have long standing collaboration history with the investigators of the Melanoma program in UPCI and have worked closely with the SPORE investigators during the last funding period. We will provide integrated support for the design and analysis of all SPORE studies in the next funding period of the SPORE.
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