The research proposed by the University of Texas SPORE in Prostate Cancer encompasses a broad range of activities, including studies in cell lines, animal models, and clinical trials. These studies will generate many different types of data, including clinical, epidemiological, biochemical, and immunohistochemical, pharmacokinetics, genotype and immunologic data. The Biostatistics and Bioinformatics Core provides comprehensive biostatistics and bioinformatics expertise to ensure the statistical integrity and to optimize data analysis of the studies by the SPORE. It will incorporate sound experimental design principles within each project that will enhance interpretability of study results, will carry out data analyses using appropriate statistical methodology, and will contribute to interpretation of results through written reports and frequent interaction with project investigators. Members of the Core participate in monthly SPORE meeting with all project investigators, ensuring that proper consideration is taken of biostatistics and data management issues during all phases of SPORE experiments. The Biostatistics and Bioinformatics Core will further provide an integrated data management system to facilitate communication among all projects and cores, which will be customized to meet the needs of the Prostate SPORE. This process includes prospective data collection, data quality control, data security, and patient confidentiality. Thus, from inception to reporting, translational experiments will benefit from SPORE resources that will be used to augment existing M.D. Anderson Cancer Center biostatistics resources.
The specific aims of the Biostatistics and Bioinformatics Core are:
Aim 1. To provide valid statistical designs of laboratory research, clinical trials and translational experiments arising from the ongoing research of the SPORE.
Aim 2. To develop and conduct the innovative statistical modeling, simulations, and data analyses needed by the Projects, Developmental Projects, and other Cores to achieve their specific aims.
Aim 3. To ensure that the results of all Projects are based on well-designed experiments, appropriately interpreted, and to assist in the preparation of manuscripts describing these results.
Aim 4. To develop integrated computational libraries and tools for producing documented, reproducible statistical analyses, and to make these tools available to all SPORE participants.
Core B personnel will collaborate with every one of the five proposed projects, will interact with the other cores and also will expect to interact with all funded development awards, and thus this core is crucially important to the SPORE. Areas where biostatistical and bioinformatics expertise are indispensable are in clinical trial, experimental design, and data analysis with integrated multi-platform data. It will be apparent from this proposal that Core personnel play a significant role in designing the proposed experiments/trials and in planning the data analysis in conjunction with an integrated data management system.
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