The Biostatistics Core (BC) provides statistical collaboration and data management support for each of the SPORE projects, the Developmental Research Program projects, the Career Development Program, and the other Cores. In the past funding period, the BC supported research, and established the infrastructure to link the Tissue and Patient Registry Cores. For this competitive renewal, the BC prepared the statistical plans for each of the four Projects, will provide data management for each of the projects, and will prepare data summaries for manuscript preparation. Each of the projects presented in this application reflects input from members of the BC on study design, and analysis plan. These projects span a wide range of approaches and analyses required. The BC builds upon the innovative and time-tested procedures and systems developed by Mayo Clinic, one of the largest statistical groups in the country whose members have collaborated on more than 10,000 clinical and basic science research studies since 1966. The BC has capability to provide statistical support across different fields, including molecular epidemiologic studies, basic science with translational, immunologic, and correlative studies, gene microarray and imaging, clinical trials, gene and mutation discovery, and information management. The comprehensive nature of the BC assures each SPORE investigator access to statistical expertise that includes collaborative development of study designs and analysis plans, state-of-the-art data analysis and interpretation, data management resources, and abstract and manuscript preparation. The BC also provides a mechanism for the management and integration of both existing and newly collected data through consistent and compatible data handling. Areas of support include database development, data form development and processing, data collection and entry, data archiving, quality control, and management of information relating to the projects and cores. This Core complements and assists the efforts of the Clinical Research and Tissue Cores by providing superior data management and experience with tissue registries. The strengths of the BC are our collaboration with each of the projects and cores, the ability to utilize the established centralized research database, the operational and statistical infrastructure already in place in the SPORE, and the breadth of expertise provided by BC personnel.
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