This proposal is the Comprehensive Cancer Center Biostatistics Unit at the University of Alabama at Birmingham (UAB) to serve as the Data Coordinating Center (DCC) for the Comprehensive Sickle Cell Centers. It is anticipated that the Sickle Cell Centers will conduct collaborative clinical research studies including clinical trials and epidemiologic studies. Furthermore, the development of a common database across Centers would provide the basis for stimulating new research initiatives. The DCC will provide data management and statistical needs for specific aspects of the Sickle Cell Centers program sharing common clinical protocols, as well as for information related to health services utilization and health outcomes. The DCC will coordinate the clinical collaboration between the sickle Cell Centers and will serve as the primary unit to collect, manage, statistically analyze, and store clinical study data; to design and develop protocols; prepare forms and the Manual of Operations; train center staff in data collection procedures; maintain the study database; monitor clinical center performance; provide patient accrual reports; perform appropriate statistical analyses of study data; and participating in the preparation of study publications. The Biostatistics Unit has considerable experience in serving as the statistical coordinating center for multicenter clinical trials groups and in providing support for Comprehensive Cancer Center and Center for AIDS Research, with a Comprehensive Sickle Cell Center and Center for Health Promotion at UAB, expertise in the medical, genetic, epidemiologic, and behavioral areas will be available to the DCC on an ongoing basis.
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