The purpose of the Biostatistics Core is to provide statistical support for the scientific projects and the cores in the Program Project. A listing of the projects and cores, with an estimate of their projected use of this core resource, is provided in Table 1. 1. Provide biostatistical collaboration for clinical research projects. This includes all aspects of the design, conduct, analysis, and reporting of the clinical studies of therapeutic interventions. Biostatistical support also extends to the protocol governing specimen collection from patients not involved in therapeutic protocols. 2. Provide biostatistical collaboration for the laboratory research studies. This includes all aspects of the design, conduct, analysis, and reporting of the molecular, genetic, biochemical and immunological studies conducted on patient or murine samples. 3. Provide biostatistical assistance in the planning and conduct of exploratory analyses linking laboratory and clinical results in the CRC databases. 4. Advise on database structure, to assure the easy flow of data into and out of the CRC databases. 5. Participate in the quality assurance of the data collected in the CRC databases. 6. Participate in the internal scientific review mechanisms of the CRC, including membership on the Internal Advisory Board, the Clinical Advisory Committee, and the Data Safety and Monitoring Board. 7. Provide a forum in which statisticians working in CLL can meet and share insights into the statistical ssues of prognostic and predictive analyses in this disease, and address the issues which arise in designing CLL-specific phase I and phase II studies.
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