Human Subjects and Clinical Phenotyping Core

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PROJECT SUMMARY/ABSTRACT – Human Subjects and Clinical Phenotyping Core The Human Subjects and Clinical Phenotyping (HSCP) Core will provide researchers with access to a full range of services to facilitate successful identification and recruitment of human subjects for basic, clinical and translational research studies in rheumatic diseases. The Core will streamline clinical research infrastructure, including study design, research ethics consultation, patient recruitment, clinical informatics and disease expertise, to advance precision medicine in rheumatic disease. We propose the following Aims for the HSCP Core: 1) To provide consultation on human subjects study design, data collection, outcome measures, and research ethics for basic, clinical and translational research studies of rheumatic disease; 2) To facilitate identification of human clinical phenotypes for research studies, leveraging collaborations between nationally recognized disease experts and clinical informaticists; 3) To offer state-of-the art data retrieval and management resources, including construction of electronic health record-enabled registries; and 4) To coordinate and provide resources for human subject recruitment and biospecimen collection. Advancing precision medicine in rheumatic diseases will require a patient-oriented approach that optimizes coordination of these highly specialized resources across projects. Key strengths of the Core include internationally renowned clinical experts in rheumatology, national leaders in clinical research and clinical informatics, expertise in human subjects research ethics, and unique expertise in including patients from high-risk and diverse populations, including racial/ethnic minorities and those with low socioeconomic status. HSCP Core services address some of the current challenges facing the research community studying rheumatic diseases. These include the need for highly accurate clinical phenotyping given the extreme heterogeneity of disease manifestations in rheumatic diseases such as systemic lupus erythematosus, vasculitis, scleroderma and others; the need to more efficiently identify and recruit patients for clinical studies, particularly those with uncommon or rare diseases or clinical phenotypes; and the current lack of coordination of research infrastructure across ongoing studies, leading to inefficiencies in patient recruitment, data collection, and data management. Innovations of the HSCP Core include leveraging robust existing clinical informatics infrastructure to bridge the divide between the vast amount of accumulating clinical data and individual investigators who are interested in specific clinical phenotypes of rheumatic diseases; querying “big data” from electronic health records to construct registries using specialized methods; and “match-making” between investigators and resources. The overall goal of these activities is to provide critical and cutting edge resources that create economies of scale for researchers conducting human subjects research in the rheumatic diseases.