Core B: Clinical Trials and Statistics

Clinical trials and Statistics Core Project Summary The Clinical trials and Statistics Core (Core B) Resource will collaborate and provide comprehensive statistics service and infrastructure support for clinical trials to all Research Projects in this 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, statistical quality control, clinical trial monitoring, data analysis and

interpretation, abstract and manuscript preparation, and data dissemination. Furthermore, when required by a specific project, Core personnel will develop and implement innovative customized biostatistics methodologies and tools in collaboration with investigators in the P01. The Core B Resource is housed in the Division of

Biostatistics and Bioinformatics, Department of Oncology at Johns Hopkins University School of Medicine. This Division comprises an active and committed group of biostatistics and bioinformatics faculty, as well as non- faculty biostatisticians and bioinformaticians, with access to state-of-the art equipment and a broad range of

expertise. Core members have a strong commitment to this P01, stemming from their long-standing collaborations with the Gastrointestinal Cancers Program. All proposed Projects make use of this Core Resource in every Aim. The primary objective of Core B is to guide and assist the project investigators in the design, conduct, and

analysis of the laboratory, translational and immunologic correlative studies, and clinical trials proposed in this P01. Each project has a primary biostatistician thoroughly versed in the subject matter associated with the project, and all projects have access to the breadth of expertise provided by Core personnel. Core members

also interact on a regular basis, and work closely with Administrative Core A and Genomic and Bioinformatics Core C, which contributes to interactions and synergy among the projects.