The research proposals in this SPORE encompass a broad range of activities, including studies with cell lines, animal models, and clinical trials. These studies will generate several different types of data. Properly designing and analyzing such a wide variety of studies will require a variety of statistical and mathematical techniques. A strong data management system also is vital to the operation of the SPORE. For the component Projects to cooperate efficiently, they must have access to relevant data. That data must be easily accessible but stored in a secure manner with assurance of patient confidentiality. Data and information must flow smoothly between projects. Data quality and integrity must be ensured by using data audit and backup procedures. Also needed is an efficient interface between the computational biology and data storage facilities provided by the SPORE Core C (Specimen Resource and Pathology Core), particularly for the large amounts of microarray and proteomics expression profiling information. To meet these needs, the Biostatistics and Data Management Core brings together several biostatisticians and other professionals with expertise in a variety of statistical and data management disciplines. Placing these individuals within the Biostatistics and Data Management Core (rather than in the individual Projects) strengthens the ability of the Projects to interact effectively. The Biostatistics and Data Management Core will provide expertise in study design, data analysis, and data management to all Projects and Cores.
The specific aims of the Biostatistics and Data Management Core are to: 1. Provide guidance in the design and conduct of clinical trials and other experiments arising from the ongoing research of the SPORE. 2. Provide the innovative statistical modeling, simulation techniques, and data analyses needed by the Projects, Developmental Research and Career Development Projects, and other Cores to achieve their specific aims. 3. Ensure that the results of all Projects are based on well-designed experiments and are appropriately interpreted. 4. Ensure that the data from all experiments and clinical trials are maintained in a secure database.
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