SOUTHWEST ONCOLOGY GROUP STAISTICAL CENTER

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This proposal describes how the Southwest Oncology Group Statistical Center would be organized and operated to provide data management and evaluation, statistical analysis, and input on design of protocols for clinical trials in cancer. It is proposed to locate the Statistical Center at the Fred Hutchinson Cancer Research Center in Seattle, Washington, under the direction of Dr. John Crowley, with Dr. Brent Blumenstein as Deputy Director. The application concentrates on the role of the Statistical Center in developing and monitoring protocols, including eligibility criteria, registration and randomization procedures, endpoint and sample size determination, trial monitoring, and analysis strategies. Data management and database management strategies are described in detail. Transition plans and plans for the future are also discussed.