Core C will provide statistical and informatics support for all four research projects, Core B (Tissue/Histology), the Developmental Research Program, and the Career Development Program. Specifically, members of the Core will: 1) 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 t)oth exploratory and confirmatory statistical analyses of data from key experiments;2) perform statistical analyses of single nucleotide polymorphisms (SNPs) and haplotypes in relation to the risk of disease progression and disease-specific survival in SCCHN patients;3) collaborate with basic scientists and clinicians in writing protocols for SPORE-supported clinical trials that are methodologically sound from a statistical perspective, and that will pass scientific, ethical, and regulatory review;4) perform interim analyses of safety for the SPORE-related clinical trials that are underway, and final analyses of the data relating to safety, efficacy, and correlative studies;5) contribute to the review of developmental research proposals, and provide statistical and informatics support for those that are funded;6) maintain and enhance a virtual repository that integrates data from clinical, questionnaire, pathologic, and molecular systems into a single architecture supported by a set of common data elements to facilitate basic-science, clinical, and translational research by the SPORE;7) work with project investigators and UPCI Clinical Research Services to ensure that requisite data are properly recorded for statistical analyses, and that systems for quality assurance and quality control for SPORE-related data are in place;8) continue the development of data-entry, data-mining and data-analysis tools, and a data warehouse for genomic and proteomic data;9) using recorded data elements in the SPORE'S organ-specific database, develop algorithms for study variables that are widely applicable to the SPORE, such as disease progression and recurrence, occurrence of a second primary, treatment with cetuximab, and use of platinum-based treatment regimens;and 10) collaborate with project investigators in writing and preparing progress reports, abstracts, manuscripts, and presentations.
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