Core 1 - Biostatistics

ABSTRACT – CORE 001: Biostatistics Core The Biostatistics Core will provide the shared biostatistical services and data coordination necessary for this Program Project. It will provide comprehensive support of the web-based surveys, lab-based studies, and the randomized cluster health communication trial from study design, sampling, data collection, quality control, and database management to biostatistical analysis and dissemination. Use of a centralized core will support the overall conceptual framework for the Program Project, resulting in consistency in measurement and analysis across studies and other cores. The Biostatistics Core draws upon the skills and expertise housed within the Department of Biostatistics and Data Science in the Division of Public Health Sciences at Wake Forest School of Medicine, a department with extensive experience serving as a data coordinating center for numerous multi- center NIH-funded studies, and from the Biostatistics Shared Resource of the Wake Forest Baptist Comprehensive Cancer Center. The mission of the Biostatistics Core is to provide a complete and well- integrated infrastructure for the collection and analysis of study data, ensuring appropriate inferences are made when disseminating results. The Aims of the core are to: 1) Provide statistical expertise on study design and sample selection; 2) Perform data management activities including database creation, quality control, integration, and sharing; and 3) Conduct statistical analyses and facilitate proper statistical inference from appropriately prepared datasets. This centralized core will provide the technical skills necessary for the collection of research data via web-based surveys and in-person laboratory procedures and will provide a skilled team for the statistical analysis of these data sets. Through a coordinated collaboration between this Core and each project, we will ensure an efficient means of collecting and analyzing data for all research projects described in this proposal. The primary objectives of the Biostatistics Core are the provision of needed biostatistical services, including design, sampling, data management, analysis, and dissemination.