CORE C (Biostatistics) will reside within the University of Pittsburgh Cancer Institute's (UPCI) BiostatisticsFacility, 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 andphase II oncology clinical trials; epidemiologic studies, including those related to cancer prevention andawareness; and investigations of behavioral and health sequelae of cancer treatment. In its role as Core Cfor this Program Project, the Biostatistics Core will support all five research projects. We will collaborate withinvestigators on statistical aspects of the design of in vitro and in vivo laboratory-based studies as new datacome to light, and perform both exploratory and confirmatory statistical analyses of the resulting data fromkey experiments in Projects 1 - 5. For the clinical trial that is planned (Project 4), we will collaborate withbasic 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 theSPORE's clinical trials (Projects 2, 3 & 4), and final analyses of their data on safety, immune response, andtreatment efficacy. We will contribute to the review of the SPORE's developmental research-programproposals, and provide statistical support to those that are funded. We will provide statistical support to thecareer-development awardees. We will work with the project investigators, with Core D (Informatics), andwith UPCI Clinical Research Services, a component of Core A, to ensure that the requisite laboratory andclinical-trial data are available for statistical analyses. We will collaborate with the project investigators inwriting and preparing progress reports, abstracts, manuscripts, and presentations.
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