Core C (Biostatistics, Bioinformatics, and Data Management) Abstract Core C (Biostatistics, Bioinformatics, and Data Management) provides expert guidance and collaboration in the biostatistical, bioinformatics, and data management aspects of the design, conduct and analysis of translational research projects generated by this P01 proposal. In order to achieve these goals, the specific aims of Core C include: 1) to consult with project investigators to select efficient study designs and sample sizes that are adequate to address study objectives, 2) to work with investigators to prepare tables and graphs, to execute efficient and robust statistical and bioinformatics analyses, to draft statistical sections of project manuscripts, and to propose and implement best design and analysis strategies for subsequent studies, and 3) to provide statistical support in data management for clinical trials, projects, and cores, and promote data sharing. Specifically, prior to the initiation of studies, Core staff members will consult with project investigators to help select designs that are efficient and adequately powered. For the proposed clinical trials, Core C will collaborate to utilize existing data management systems or establish new ones if required, and design case report forms (CRF) that collect all required information in an unambiguous way. As studies proceed, staff members review data periodically to evaluate adherence to study procedures, data quality, and adequacy of underlying statistical assumptions. When studies are finished, staff members review the data again, produce informative summary tables and graphical displays, conduct correct and efficient statistical and bioinformatics analyses, and consult on the design of subsequent studies. The work of Core C involves close integration with the efforts of all the research projects. Core C staff members have extensive experience supporting cancer research, with strong backgrounds in basic science, translational research, clinical trials, bioinformatics, research computing, and data management. With their many years of experience in biomedical research, they stand ready to identify and apply ideal methods for the design and analysis, and data management of the proposed research studies. Core C offers its services to all projects and cores in this P01 proposal.
Core C (Biostatistics, Bioinformatics, and Data Management) Narrative The primary function of Core C (Biostatistics, Bioinformatics, and Data Management) is to enhance the productivity of program project investigators by providing them with access to a team of biostatisticians and bioinformaticians who have experience with biostatistical and bioinformatics methodology and their application to clinical trials and other biomedical research studies. Through active collaboration with project investigators at every stage of the research, this Core will insure that the proposed studies will have high quality study designs and statistical analysis plans that enable project investigators to efficiently acquire knowledge and draw valid conclusions from their fast-expanding sources of information with the ultimate goal of improving health through translational research.
