Based on a strong track record of providing biostatistical support and data management infrastructure for translational research, the Biostatistics and Data Management Core (BDMC) of the University of Texas M.D. Anderson Cancer Center (UTMDACC) Head and Neck SPORE is a comprehensive, multi-lateral resource for acquiring, managing, and integrating data, designing clinical and basic science experiments, performing statistical analysis, building comprehensive risk assessment models, developing innovative statistical methodology, and publishing the research results generated from this H&N SPORE. In our first funding cycle, BDMC significantly enhanced the database infrastructure for the M. D. Anderson Head/Neck Tissue Bank and the Oracle Clinical Database for two clinical trials. We have developed and posted on-line the first common data element (CDE) for the head and neck tissue bank. Based on the CDE's, we built a comprehensive, web-based, data management system for the tissue bank that now stores over 338,000 tissue samples (fresh, paraffin, slide, or fluid samples) from more than 29,000 patients. The Tissue Bank Data Management System also provides extensive query and reporting capabilities. In addition, in collaboration with staff at NCI, we have developed two clinical trial data management systems, based on Oracle Clinical, which allows for remote data capture and is ideal for expanding for inter-SPORE collaborations. For this renewal application, we will continue to ensure the incorporation of sound experimental design principles within each project that will increase the clarity and enhance interpretability of study results. Each project will be provided with tailored analyses, accompanied by novel statistical development as necessary, to reveal apparent and hidden relationships among data. The BDMC will provide expertise in the design of an integrated data management system to facilitate communication among all projects and cores. This process includes prospective data collection, data quality control, data security, data management, data integration, and assurance of patient confidentiality. The BDMC will continue to provide statistical support for the entire HN SPORE, including design of in vitro/in vivo experiments, clinical trials, sample size/power calculations, statistical data analysis, preparation of statistical reports for clinical trials, and collaborating in the development of related publications.
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