CLINICAL SCIENCES CORE (CORE C) The Clinical Sciences Core (CSC;Core C) will be the focal point of all D-CFAR clinical and translational research activities. A major goal for the Core will be to provide expertise and services to facilitate the design, implementation and conduct of HIV/AIDS clinical trials by D-CFAR investigators. The Core will be directed by Dr. Michael Keefer, who has extensive administrative and clinical research experience. The Core will provide support for clinical and translational research by developing a """"""""Protocol Team Service"""""""" that draws on the 20 year experience of the major UR HIV/AIDS clinical research programs. While fiscal restraints obviously limit the extent to which a """"""""network-like"""""""" support structure can be established, our extensive expertise will allow us to proceed in a step-wise fashion to provide an 'investigator-centered'service that addresses the most pressing needs that clinical researchers face as they design, implement and conduct their studies. The """"""""Protocol Team Service"""""""" will also leverage other expertise within the D-CFAR and the UR institution as a whole to present a coordinated menu of services that the program's D-CFAR investigators can access. Intellectual assistance will be provided through a """"""""protocol design"""""""" service, and laboratory assays provided in collaboration with the Virology/Immunology Core (Core D). A second area of focus for Core C will be the creation of a """"""""Biostatistical Service"""""""" designed to meet investigator needs that were identified during the strategic planning process for this D-CFAR application (including the needs of international partners in South Africa;see below). The third area of emphasis will be on """"""""Specialized Services"""""""" - notably biomathematical modeling (which is a major institutional strength at UR) and clinical pharmacology services. Finally, the activities and services of Core C will be designed to build upon the growing collaboration that the UR is nurturing with successful research colleagues in South Africa. Dr. Keefer's current close working relationship with Dr. Glenda Gray (U-Witwatersrand [UWj / Perinatal HIV Research Centre [PHRU]) and Dr. Linda-Gail Bekker (U-Cape Town [UCT] / Desmond Tutu HIV Centre [DTHC]) through HVTN operations will form the initial foundation of the collaboration. It is our goal for the UR-South African collaboration to evolve into a broad-based inter-institutional collaboration in years to come.
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