Nature and Importance of the Biostatistics and Data Management Core. The Biostatistics and Data Management Core for the M.D. Anderson Genitourinary Cancer SPORE will serve multiple needs for the planning and conduct of the SPORE's translational research. This resource will be used for hypothesis refinement, experimental design, data management, quality control, resu7lt analysis and informative presentation of refinement, experimental design, data management, quality control, result analysis and informative presentation of results, and will function across all projects of the SPORE. From a biostatistical perspective, design and analysis of laboratory and clinical projects will be performed in collaboration with Dr. Yu Shen, Dr.. Dennis Johnston, Dr. Dorota Doherty and Mr. Mark Munsell. From a clinical and informatics perspective, Core services will be provided in collaboration with Dr. Randall Millikan. Data from SPORE clinical trials and laboratory projects will be entered into a custom database application recently launched within the Center for GU Oncology. Among other advantages, this computerized database will facilitate continuous monitoring of clinical trial results and will allow for automated data audits. This, from inception to reporting, translational experiments will benefit from SPORE resource that will be used to augment existing M.D. Anderson biostatistics resources and to align these considerable resources with SPORE research objectives.
The specific aims of the Biostatistics and Data Management Core are: 1. To provide guidance in the design and conduct of clinical trials and other experiments arising from the ongoing research of the SPORE. 2. To provide the innovative statistical modeling, simulation techniques, and data analyses needed by the Projects, Developmental Projects, and other Cores to achieve their Specific Aims. 3. To ensure that the results of all projects are based on well-designed experiments and are appropriately interpreted.
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