Clinical Sciences Core

Modified Project Summary/Abstract Section Clinical The CFAR Clinical Sciences Core (Core C) provides unique clinical resources and scientific leadership for the largest network of HIV investigators in South Florida and promotes high impact HIV translational and multidisciplinary human subjects research through partnerships with clinical, socio-behavioral, and basic scientists. Under the leadership of Dr. Maria Alcaide (Core Director) and Dr. Charlie Mitchell (Co-Director), in collaboration with the Biostatistical Sub-Core, Core C has supported over 70 investigators, 124 studies, and almost 200 publications over the past 4 years. Core C has significantly contributed to the success of junior investigators. The success of Core C is strengthened by strong institutional support for HIV research (one of the pillars of the University of Miami strategic plan for research), and by facilitating the access to institutional programs not commonly supporting HIV research. The specific aims for Core C are: Aim 1) To provide state-of-the-art facilities for implementing clinical and translational studies, including support for rigorous clinical assessments, biological sample collection, and access to well- characterized high-quality data. Core C supports fully equipped and staffed research static and mobile units, and the development of CFAR databases; Aim 2) To provide research design methodology and technical assistance to meet regulatory standards in research involving human subjects, human data, and biological specimens, and to facilitate training/education of investigators in clinical research. Research methodology needed in key areas will be provided by the highly qualified and experienced Core C investigators and staff, and training will be accomplished by facilitating the use of institutional resources not commonly used by HIV investigators; and Aim 3) To provide biostatistical support throughout the project lifecycle, through the CFAR Biostatistics Sub-Core. Core C biostatisticians will collaborate in planning study design for pilot studies, formulate statistical approaches consistent with study aims, guide the development of data collection tools using electronic data entry systems, support statistical analysis and interpretation, and participate in the development of manuscripts and grant submissions. Without support from Core C research units, highly qualified clinical staff, robust databases and biostatistical support; Miami CFAR investigators would not be able to conduct high impact multidisciplinary research that will slow the progression of the epidemic in South Florida, and ultimately, end the HIV epidemic in the US.