This is a continuation of an existing, well-functioning and absolutely essential Core. During the previousfunding period, the Core provided extensive biostatistical and data management support to all five projects,to both the Pathology Core and the Tumor Bank Core, and to several of the Developmental Projects,resulting in more than 30 coauthored publications, many in high impact journals. All projects in our newSPORE application will require substantial statistical support for a range of preclinical and clinicalexperiments. In our experience, centralized biostatistical support ensures that the biostatisticians arecompletely familiar with all aspects of the Projects and Cores. This provides continuity, increases efficiency,and ensures that appropriate methods are applied.
The specific aims of the Core B (Biostatistics and DataManagement) are to: (1) Provide comprehensive biostatistical and bioinformatical consultation, data analysisand reporting; (2) Provide comprehensive support for conduct and analysis of clinical trials, including dataquality control and monitoring, interim monitoring and analysis of data, final analysis, and reporting; (3)Develop and maintain databases and database applications in support of Projects and Cores. The SPOREbenefits greatly from having a dedicated and experienced team of analysts with a range of skills. Forexample, analysis of microarray experiments is especially demanding and complex and will require bothbiostatistical and bioinformatic expertise. Core analysts are active participants in all aspects of the SPORE.Sample size considerations, experimental designs, and overviews of planned analyses for all projects wereprepared in collaboration with the Core, and are provided within each project and specific aim. In addition,deep understanding of Project and Core data and analysis needs, in turn, drives database development,ensuring that database solutions meet the broad as well as project-specific needs of the SPORE. Corepersonnel can also help the investigators design new studies and test new hypotheses that may arise bycross-fertilization of these related projects. Finally, Core leaders are highly experienced biostatisticians, whohave longstanding collaborative relationships with all SPORE investigators and other Core leaders, and whoare members of the Biostatistics Shared Resource of the Dan L. Duncan Cancer Center at Baylor College ofMedicine, thus facilitating a close integration with the Cancer Center.
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