Core H: Outcomes and Biostatistics Core (Clinical Research Core) Staff of the core will include Core Director Ira Wilson, M.D., Assistant Professor of Medicine at Tufts University School of Medicine and a scientist in the Primary Care Outcomes Research Institute of the New England Medical Center. Dr. Wilson will oversee the outcomes analysis function of the core and coordinate the Biostatistics Subcore at Brown University. Joseph Hogan, Sc.d., Assistant Professor of Biostatistics at Brown University, will serve as director of the Biostatistics Subcore. Constantine Gatsonis, Ph.D., Director of the Center for Statistical Services at Brown University, will serve as co-director of this subcore. They will oversee and coordinate all biostatistical analysis performed by the CFAR. Lucy Hanna, M.S. will serve as the biostatistician and statistical programmer for the subcore. Basic purposes of the core will be 1) to provide consultative services to collaborating investigators concerning the design, collection and analysis of health-related quality of life (HRQL) data from clinical studies; 2) to create an outcomes database that will contain a core set of HRQL data from a variety of studies; and 3) to provide a broad range of biostatistical services to collaborating investigators. These will include experimental design advice, power calculations in the planning phases of studies, data collection and management services, psychometric analyses and complex multi-variable modeling. Key scientific studies to be supported by this core include the CDC-funded HIV Epidemiology Research Study (HERS; PI. Charles Carpenter, M.D.); Dr. Susan C-Uvin's study of the effect of highly-active anti-retroviral therapy on viral load in the female genital tract, Dr. Sherwood Gorbach's Nutrition for Life program project, and Dr. Kevin Vigilante's comprehensive care project for incarcerated women and substance abusing women (funded by HRSA).
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