Biostatistics and Informatics Core

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The Biostatistics and Informatics Core (BIC) brings together biostatistical, informatics and database experts to support the information and analysis needs ofthe individual SPORE projects, cores, and leadership. The BIC serves two key roles. The first is to provide basic statistical analysis support to all projects and cores. Highlights of this activity in the past have been the development of procedures for quality control and normalization of high throughput bead-based assay platforms, and statistical methods for combining, evaluating and using biomarkers in screening studies. The second key role includes managing the data from projects and cores. Highlights of this activity has been the development of a comprehensive informatics system that currently maintains data for over 200,000 unique specimens from 3000 women enrolled in our studies, including all associated clinical, epidemiological and research assay data, and coordination of several inter-spore collaborations. ' During the next phase the BIC will continue to manage each project's information needs and assist in facilitating high quality data analysis. Specific statistical research support will include the revision of methods for using multiple biomarkers over time in a screening study (prospective screening project), and development of statistical techniques for the discovery of multigene Component Patterns (CPs). Specific developments for data management include new methods for management of specimen repository data (all projects), expanding the web-based Informatics System to support the work of the Informatics Coordinating Center for Project 1's Novel Markers Randomized Control Trial, expanding support to manage Phase 1 clinical trials described in Projects 2 and 5, and completing our efforts to obtain caBlG compliance. Because ofthe experience and capabilities ofthe BIC Informatics System, we were selected by GenoLogics to serve as a development partner for their next-generation comprehensive information system, including components of sample tracking, query, and data sharing. With support from the Canary Foundation and FHCRC we will transition to the GenoLogics platform in 2009. GenoLogics will market their system worldwide.