Project Summary The Biostatistics Core (Core C) will collaborate and provide comprehensive statistics service and infrastructure support for clinical and pre-clinical studies to all Research Projects in the proposed Program Project Grant. In addition, it will provide support for data management and integration, informatics, and computing, and assist with the identification and solution of complex data tasks arising in the course of project activities. Core members will work with project investigators across a wide spectrum of activities, encompassing formulation of the study design, data acquisition and database management, statistical quality control, patient study monitoring, data analysis and interpretation, abstract and manuscript preparation, and data dissemination. Furthermore, when required by specific project, Core personnel develop and implement innovative customized biostatistics methodologies and tools in collaboration with investigators in the P01. The Core C Resource is housed in the Division of Biostatistics and Bioinformatics, Department of Oncology at Johns Hopkins University School of Medicine. The Division comprises an active and committed group of biostatistics and bioinformatics faculty, as well as non-faculty biostatisticians, bioinformaticians and IT specialists, with access to state-of-the art methodologies and a broad range of expertise. Core members have a strong commitment to this P01, stemming from their long-standing collaborations in the research of αRPT. All proposed Projects make use of this Core Resource in every Aim. The primary objective of the Core C is to guide and assist the project investigators in the design, conduct, and analysis of the laboratory, translational, and clinical studies proposed in this P01. The program has dedicated biostatisticians thoroughly versed in the subject matter associated with the projects, and all projects have access to the breadth of expertise provided by Core personnel. Additionally, Core members interact on a regular basis, and work closely with the Administrative Core A and Animal Models, Pathology and Tissue Core (Core B) and Patient Data Core (Core D), which contributes to interactions and synergy among the projects.