In support of CFAR investigators, the Core will provide biostatistical, statistical genetics, biomedical informatics and data coordination expertise. The Core continuation will provide ongoing centralized investigator access to services essential to successful basic, translational, and clinical HIV/AIDS-related research. During the first five years, the Core provided: 1) biostatistical support of study design and analysis and 2) data coordination and biomedical informatics support. Data coordination and informatics activity yielded a state-of-the-art Clinical Core Cohort Registry (HIV+ patients) and Data Warehouse - a centralized data repository for HIV+ patients that contains vital scientific data from many sources, including the UPENN Health System. The overarching Core continuation goals will be to (1) assist Investigators with fully utilizing CFAR informatics infrastructure (e.g., data from the Data Warehouse) to develop clinical research project and proposal concepts and (2) provide a wide range of biostatistical support, including statistical genetics for comprehensive study design and analysis. This paradigm has been utilized very successfully to increase high quality NIH-sponsored HIV/AIDS-related research at UPENN, including prevention clinical trials. Biostatistical specific aims for basic and clinical research are to i) advise on study design issues; ii) (re)define and/or refine study hypotheses; iii) conduct sample size/power analyses; iv) conduct statistical analyses; v) assist with preparation of final reports, abstracts, manuscripts, and future research proposals; and vi) conduct exploratory analyses that may lead to generation of new hypotheses. Collaborations resulting in translational research will be fostered through centralized access to biostatistics co-investigators who will consult on study design and analysis; eventually bringing positive basic science results to the attention of clinical researchers. Data coordination and informatics specific aims are: i) provide informatics expertise to help investigators explore Warehouse data (e.g., assemble existing patients into cohorts meeting proposed eligibility criteria) for proposals and ii) design data collection instruments, management, and databases for proposals. The Core will contribute to research quality by consulting with investigators to develop standardized methodologies for data collection and management, while emphasizing the necessity for compliance with applicable FDA and ICH (International Conference for Harmonization) guidelines. Industry collaboration and funding will be encouraged through assurances that research is conducted in a manner consistent with regulatory requirements.
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