Core B will provide comprehensive and centralized support that integrates the biostatistical activities and data management for the clinical trials and laboratory projects proposed by investigators from the MD Anderson Cancer Center (MDACC), Baylor College of Medicine (BCM) and the University of Texas Institute of Molecular Medicine (IMM). Core Director, Dr. Donald A. Berry, and the Co-Director, Dr. Hao Liu, will coordinate the biostatistical support using a centralized web-based data management system. Core activities will be a team effort, with every member contributing his/her area of specialization. Team members from MDACC and BCM have substantial experience in collaborative activities. Explicit issues addressed in this Core include statistical study design, data analysis and data management. Core B provides statistical support for all projects, including the related data management and computing components.
The specific aims of Core B are to: 1) coordinate and manage the statistical activities to ensure that investigators have ready and dedicated access to biostatistical consultation, 2) provide statistical design, planning, and conduct of clinical trials and preclinical validation, 3) provide comprehensive support for data analysis including futility/safety/toxicity monitoring, interim reviews of data, final analysis, interpretation and reporting, and 4) coordinate data management activities in close collaboration with the Administrative Core. In addition, Core B will support the bi-institutional clinical trials (MDACC and BCM only) of all Projects by providing computing facilities and resources for research requirements and by implementing patient-specific data management. This includes data review, transfer, sharing, and security as well as quality control and protocol compliance. This Core will provide biostatistical support to all four research Projects. Centralized biostatistical support will ensure that biostatisticians are familiar with the unique as well as the interrelated aspects of each Project and provide and infrastructure for interactions among biostatisticians and investigators. Consequently, this will 1) facilitate efficient use of biostatistical services, 2) provide an opportunity for dynamic collaboration between biostatisticians and investigators in the design, conduct, and interpretation of data resulting from the Projects, and 3) ensure the conduct of high-quality projects in a tri-institutional environment. The Core personnel are highly experienced biostatisticians who are members of the Biostatistics Shared Resources of MDACC and the Dan L. Duncan Cancer Center at BCM.
The implementation and development of statistical designs and analytic tools are critical to the success of the Program Project, where novel statistical input is required. The Core will provide comprehensive and centralized statistical activities for preclinical studies and clinical trials, with the support of a centralized web-based data management system. The iterative approach for preclinical and clinical studies in the Program Project requires effective interaction and collaboration between the statisticians and the research PIs. Experienced statisticians from BCM and MDACC can bring substantial team effort to the projects.
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