The Biostatistics Core is responsible for providing coordinated, centralized data management support along with comprehensive biostatistical consultation, data analysis and reporting to all aspects of the projects related to this application. The proposed projects include two multi-center biomarker modulation clinical trials (Projects 1 and 2), and a related laboratory-based project (Project 3). Successful execution of the clinical studies will require close coordination among participant investigations, and with the Pathology Core. This will be facilitated by centralizing clinical data management activities in the Biostatistics Core. Similarly, central data management will facilitate linkage of results for Project 3 arising from within the project and from assays performed by the Pathology Core. We have considerable experience in data management of this type and anticipate no problems in supporting the needs of these projects. Centralized biostatistical support of all projects will also be an asset to the projects. It ensures that the biostatistician will be completely familiar with all aspects of the projects. In addition to overseeing and accomplishing planned analyses in an orderly and timely way, core personnel can help the investigators formulate and test new hypotheses that may arise by cross fertilization of these closely related projects.
