GI malignancies are a complex constellation of diseases, most likely caused by the complex interplay between genes and environmental factors; only a small proportion of these tumors are caused by a known germline mutation. Therefore, large-scale research projects, such as the ones proposed in this GI SPORE application, are necessary to have an impact on early detection, diagnosis and prevention. We will therefore develop a centralized Biostatistics Core infrastructure for data management, study design, and statistical analysis, to allow integration of data across all research projects and Cores within the SPORE. This Core will meet a broad assortment of requirements for both the SPORE as a whole and for each individual project and Core, leading to many scientific manuscripts and submission of additional grants and pilot projects.
The overall goal of the Biostatistics Core of the GI SPORE is to provide the necessary expertise and support in experimental design and biostatistics, genetic epidemiology and Illumina sequencing statistical analysis and interpretation, in order to promote and enhance the research projects and Cores. It will thus provide a Core service across all SPORE activities, enhancing and improving the quality of the research undertaken.
The Biostatistics Core is drawn from faculty and resources in the Biostatistics Shared Resource of the Case Comprehensive Cancer Center (CCCC) and the Department of Epidemiology and Biostatistics of Case Western Reserve University (CWRU) School of Medicine. We draw from resources being developed and supported by the CCCC in data management, informatics and Illumina sequencing analysis. Drs. Jill Barnholtz-Sloan and Robert Elston will co-direct this Core facility; both are members of the CCCC and the Department of Epidemiology and Biostatistics, Dr. Elston being currently the chair of the Department.
Aim 1: To provide statistical analysis consultation, expertise and resources to enhance discovery for gastrointestinal (GI) malignancies. The Core will assist investigators with all facets of statistical analysis and interpretation. Both established and novel, tailored analytic methods are available to promote scientific discovery for GI malignancies within the Core. The Core will facilitate access to existing CCCC informatics systems to link them with project specific databases, facilitating statistical analysis, discovery and collaboration.
Aim 2: To provide expertise required for the statistical analysis of Illumina sequencing data. The Core will provide the expertise necessary to appropriately analyze sequencing data through constant monitoring for, and comparison of, available techniques and so utilization of state-of-the-art techniques.
Core personnel will interact with SPORE investigators in all stages of research, from the formulation of the research questions, through experimental design, data management, data analysis (including outcomes analysis), interpretation, writing scientific manuscripts and grants, to dissemination of results. The Core has demonstrated expertise in development of novel approaches to the analysis of complex disease data. The Biostatistics Core will provide a natural foundation for cross-pollination among the projects, the Core personnel collaborating with all project investigators and Core directors.