Based on a strong track record of providing biostatistical support and data management infrastructure fortranslational 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 resourcefor acquiring, managing, and integrating data, designing clinical and basic science experiments, performingstatistical analysis, building comprehensive risk assessment models, developing innovative statisticalmethodology, and publishing the research results generated from this H&N SPORE. In our first fundingcycle, BDMC significantly enhanced the database infrastructure for the M. D. Anderson Head/Neck TissueBank and the Oracle Clinical Database for two clinical trials. We have developed and posted on-line the firstcommon data element (CDE) for the head and neck tissue bank. Based on the CDE's, we built acomprehensive, web-based, data management system for the tissue bank that now stores over 338,000tissue samples (fresh, paraffin, slide, or fluid samples) from more than 29,000 patients. The Tissue BankData Management System also provides extensive query and reporting capabilities. In addition, incollaboration with staff at NCI, we have developed two clinical trial data management systems, based onOracle Clinical, which allows for remote data capture and is ideal for expanding for inter-SPOREcollaborations. For this renewal application, we will continue to ensure the incorporation of soundexperimental design principles within each project that will increase the clarity and enhance interpretabilityof study results. Each project will be provided with tailored analyses, accompanied by novel statisticaldevelopment as necessary, to reveal apparent and hidden relationships among data. The BDMC willprovide expertise in the design of an integrated data management system to facilitate communicationamong all projects and cores. This process includes prospective data collection, data quality control, datasecurity, data management, data integration, and assurance of patient confidentiality. The BDMC willcontinue to provide statistical support for the entire HN SPORE, including design of in vitro/in vivoexperiments, clinical trials, sample size/power calculations, statistical data analysis, preparation of statisticalreports for clinical trials, and collaborating in the development of related publications.
Showing the most recent 10 out of 370 publications
