The Biostatistics Core will provide statistical support for the research conducted in the Glioma SPORE program, including related database and computing requirements. The Core will provide consultation and expertise on the development and implementation of plans for data collection, particularly the coding convention and variable format required for statistical analysis. The Core will contribute to the data management plan, including form design and database requirements, during development of the SPORE-related clinical trials. The Core will provide expertise and resources for data transfer, merging, sharing and security while maintaining the confidentiality of all patient-related protected health information. The Core will provide ready and dedicated access to statistical expertise for the design, planning and conduct of preclinical experiments, clinical trials and correlative tissue and biomarker studies. Analysis of the clinical trials will include interim monitoring, if necessary, including the stopping rules for safety and futility. The Core will also provide statistical expertise for data analysis and interpretation of research studies, including manuscript preparation.
The Biotatistics Core is critical to this research program in order to ensure that the proposed studies will satisfy the prevailing and emerging scientific standards for statistical rigor. Successful translation of the preclinical and clinical studies to patient care can be accomplished only ifthe studies were statistically valid in terms of experimental design, data analysis and overall interpretation.
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