Clinical Investigation

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The UCSD CFAR Clinical Investigation Core promotes translational, epidemiologic, and outcomes research in HIV disease by providing access to an established and successful infrastructure. The objectives of the Core are as follows: (1) provide the services, expertise, and environment necessary for clinical investigation and translational research; (2) provide access to a longitudinal database for epidemiologic, behavioral, and outcomes research; (3) foster communication and collaboration between basic and clinical investigators in academics and industry; (4) support training of junior HIV investigators and education of medical personnel; and (5) provide education and awareness of HIV-related research opportunities and CFAR research findings to all HIV-infected individuals, including women and minorities. To meet these objectives, the resources of a large, well-established clinical trials unit are made accessible to a broad range of clinical investigators for pilot and funded projects. Physicians, basic scientists, pharmacists, fellows, junior faculty, and students use Core services. The Core has also processed requests from academic institutions outside UCSD. The Core provides a full range of services, including patient outreach and recruitment; specimen collection; data collection, entry, and analysis; trial design consultation; training of clinical research personnel; and access to a longitudinal, 5,000-patient database containing cumulative clinical, behavioral, and laboratory indicators for epidemiologic- and outcomes-related research. In addition, the Core Directors and affiliated experienced investigators mentor junior investigators and participate in CFAR didactic courses in clinical research methods and biostatistics. The opportunities for outcomes and translational work have been expanded with the CNICS (CFAR Network of Integrated Clinical Systems) project, a collaboration of seven CFAR sites with electronic medical records databases. Core personnel have facilitated the addition of resistance data to the CNICS cohort. In addition, the Core supports an extensive community outreach and education program, which includes concerted efforts to reach women, minorities, and injection drug users. CFAR support of the Clinical Investigation Core has enabled the development of new funded programs, scientific collaborations, and numerous abstracts and publications. Future plans include (1) expanding outcome, resistance and translational research through the CNICS collaboration; (2) expanding the Core's current database to include patient-based measures and enhanced quality assurance of data elements; and (3) fostering multidisciplinary research in the many complications and co-infections that accompany