Clinical Core D

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PROJECT SUMMARY – CLINICAL AND BIOSTATISTICS CORE D The Texas Developmental Center for AIDS Research (D-CFAR) is based at Baylor College of Medicine (Baylor) and University of Texas Health Science Center at Houston (UTHealth) and the Texas Biomedical Research Institute (TxBiomed) in San Antonio. A strategic planning process demonstrated need for clinical and biostatitistical research support among both established and early stage investigators at the home institutions. The Texas D-CFAR will therefore establish a Clinical and Biostatistics Core (CBC, Core D) to capiltalize on the resources and expertise of HIV investigators and biostatisticians to facilitate high-impact clinical, translational and basic science research aimed at Ending HIV and Optimizing HIV Health in Texas. The Core leadership team has extensive experience in study design, clinical research, and research implementation, and data management and analysis. It also is well connected with national biobanks and repositories and is thus positioned to reach and support a diverse array of investigators. Texas D-CFAR investigators and affiliated users, whether junior or new to HIV research or the participating institutions, may lack knowledge of how to design, initiate and implement studies; how to obtain or access clinical samples or data; and/or how to design and execute appropriate and reliable data management and analytic plans. The CBC goal is to fill that gap. To do this, Core D will provide project development and implementation services for investigators who are junior or new to HIV research or D-CFAR institutions; provide access to human tissue and blood samples, facilitating clinical, translational and basic science research; and provide data analysis, data management and consultative biostatistical services to investigators who are junior or new to HIV research or D-CFAR institutions. The D-CFAR CBC will stimulate through mentorship and recruitment and facilitate through project implementation high-impact research, meeting the current and anticipated clinical, translational and basic science research and educational needs of local investigators, the NIH and our local communities of people with and at risk for HIV. The Core leadership, in collaboration with the D-CFAR leadership, has identified a comprehensive action plan, set of activities, policies and procedures and evaluation metrics to ensure success. Through accomplishing our aims, we will move toward our goal of Ending HIV and Optimizing HIV Health in Texas and be able to transition to full CFAR funding in 5 years.