Core G - The Clinical Investigation and Biostatistics (CB) Core supports and enables studies of the pathogenesis, treatment, and prevention of HIV disease and its complications. The Core functions as a central access point for basic, clinical, and translational investigators by providing expertise in clinical study design, study implementation, patient recruitment, clinical evaluations for research, and specimen and data collection. Importantly, the Core provides biostatistical consultation for study design, grant preparation, power considerations and statistical analysis of study results as well as assistance with manuscript preparation. The CFAR web portal allows users to submit requests to the CB Core in a uniform, easy-to-use, and readily available format that ensures rapid response to requested services. A key innovation of the CB Core is the availability of prospectively collected, high quality, real-time clinical data, from the 3000 patients in current clinical care at the Owen Clinic, which is linked to a specimen repository and patient-based outcome measures (i.e., quality of life, adherence). The data and specimens allow for identification of and access to subjects and specimens that meet specific criteria for interventional, epidemiologic, behavioral, or basic science projects. The Core interacts with other CFAR cores to enable research requiring laboratory and clinical expertise, fosters multidisciplinary research among basic, clinical, and behavioral scientists, and teaches and mentors junior investigators in the principles of clinical investigation. CFAR funding permits the CB Core to offer its services to new and junior investigators without charge in most cases. Quality-assured data sets, with key data elements that have been reviewed for consistent definitions and accuracy, are provided free to the CFAR academic community. The resources from the CB Core have been further expanded and leveraged by collaboration with seven additional CFARs across the country to form the CFAR Network of Integrated Clinical Systems (CNICS).
The specific aims of the CB Core are: to support clinical investigation and translational research;to encourage, mentor and train the next generation of HIV clinical investigators;and to provide education about and access to HIV-related research opportunities and CFAR research findings to all HIV-infected individuals, including women and underrepresented minorities in the CFAR community.

Public Health Relevance

The Clinical Investigation and Biostatistics (CB) Core promotes and enables research aimed at important questions concerning the pathogenesis, treatment, and prevention of HIV disease and its complications. The Core functions as a central access point for basic, clinical and translational investigators by providing key resources including expertise in study design and implementation, statistical analysis, patient recruitment, research clinical evaluation and specimen and data collection.

National Institute of Health (NIH)
Center Core Grants (P30)
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Special Emphasis Panel (ZAI1)
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University of California San Diego
La Jolla
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Heaton, Robert K; Franklin Jr, Donald R; Deutsch, Reena et al. (2015) Neurocognitive change in the era of HIV combination antiretroviral therapy: the longitudinal CHARTER study. Clin Infect Dis 60:473-80
Hepler, N Lance; Scheffler, Konrad; Weaver, Steven et al. (2014) IDEPI: rapid prediction of HIV-1 antibody epitopes and other phenotypic features from sequence data using a flexible machine learning platform. PLoS Comput Biol 10:e1003842
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