Although this is a new SPORE application, the team represented by this Core is not new to SPOREs or to multi-project programs of research. During our previous Breast SPORE, the Core provided extensive biostatistical and data management support to all five projects, to both Core A (National Tissue Resource) and Core C (Pathology), and to several of the Developmental Projects, resulting in a total of 39 coauthored publications, many in high impact journals. All projects in our new SPORE application will require statistical support for a range of preclinical and clinical experiments. All four projects propose clinical trials, and we have a strong track record of electronic clinical trial data management for both small single institution trials and more complex randomized multi-institution trials. We also provide data management support to Core A (National Tissue Resource and Pathology). Indeed, new informatic development in support of banking and clinical annotation, undertaken and cost shared with several other large projects, will be a major focus for the funding period. In our experience, centralized biostatistical and informatics support ensures that the biostatisticians and informatics professionals are completely familiar with all aspects of the Projects and Cores. This provides continuity, increases efficiency, and ensures that appropriate methods are applied.
The specific aims are to: (1) Provide comprehensive biostatistical and bioinfonnatics consultation, experimental design, data analysis and reporting for all SPORE-related studies, including assistance in the design, conduct and analysis of clinical trials;(2) Develop new databases and maintain and enhance existing databases, and database and web applications in support of Projects and Cores. The SPORE benefits greatly from having a dedicated and experienced team with a range of skills. The Core can also draw flexibly on the resources and personnel in the Cancer Center Biostatistics and Informatics Shared Resource to augment expertise, or alter access to resources as needs change. Sample size considerations, experimental designs, and overviews of planned analyses for all projects were prepared in collaboration with the Core. In addition, deep understanding of SPORE data and analysis needs, in turn, drives database and application development, ensuring that informatic solutions meet the broad, as well as project-specific, needs of the SPORE. A hallmark of SPOREs is flexibility to terminate futile studies and pursue new leads. With dedicated Core personnel, we can also help investigators design new studies and test new hypotheses that may arise by cross-fertilization of these related projects.
This Core provides comprehensive and essential statistical and data management support to all projects and to the other Cores. Bringing the best possible methods to bear, helps ensure that the translational goals of the SPORE are met with minimum use of resources.