Human Subjects and Clinical Phenotyping Core

人类受试者和临床表型核心

• 批准号: 10007631
• 负责人: Patricia P Katz
• 金额: $ 23.3万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-21 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10007631
• 关键词: Abnormal coordination; Address; Basic Science; Big Data; Bioinformatics; Clinical; Clinical Data; Clinical Informatics; Clinical Research; Clinical Trials; Collaborations; Collection; Communities; Consultations; Data; Data Collection; Data Management Resources; Data Storage and Retrieval; Database and Analysis Portal; Disease; Doctor of Philosophy; Education; Electronic Health Record; Ensure; Ethics Consultation; Goals; Grant; Human; Human Resources; Human Subject Research; Immunology; Individual; Infrastructure; International; Longitudinal cohort study; Methods; Outcome Measure; Outcome Study; Patient Recruitments; Patients; Phenotype; Population Heterogeneity; Rare Diseases; Registries; Research; Research Design; Research Ethics; Research Infrastructure; Research Personnel; Research Project Grants; Resources; Rheumatism; Rheumatology; Science; Scleroderma; Services; System; Systemic Lupus Erythematosus; Technology; Translational Research; Vasculitis; base; clinical phenotype; data management; data sharing networks; data warehouse; disease heterogeneity; disease phenotype; ethnic minority population; experience; high risk population; human subject; informatics infrastructure; innovation; interest; low socioeconomic status; novel; outreach; patient oriented; precision medicine; programs; racial and ethnic; recruit; research study

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.

项目摘要/摘要 - 人类受试者和临床表型核心 人类受试者和临床表型（HSCP）核心将为研究人员提供完整的机会 促进基本，临床和 风湿性疾病的翻译研究。核心将简化临床研究基础设施， 包括研究设计，研究道德咨询，患者招聘，临床信息和疾病 专业知识，以促进风湿病的精确医学。我们提出以下目标 核心：1）提供有关人类受试者研究设计，数据收集，结果指标和 基础，临床和翻译的风湿性疾病研究伦理； 2）促进 识别人类临床表型用于研究研究，利用全国性的合作 公认的疾病专家和临床信息； 3）提供最先进的数据检索和 管理资源，包括建设电子记录的注册机构；和4）到 协调并为人类受试者招募和生物循环收集提供资源。前进 风湿性疾病中的精密药物将需要以患者为导向的方法，以优化 这些高度专业的资源跨项目。核心的关键优势包括国际知名的 风湿病学的临床专家，临床研究和临床信息的国家领导者，专业知识 人类受试者研究伦理和独特的专业知识，包括高风险和潜水员的患者 人口，包括种族/族裔少数民族和社会经济地位低下的人群。 HSCP核心服务 解决研究社区研究风湿病的一些当前挑战。这些 包括鉴于疾病的极端异质性，需要高度准确的临床表型 风湿性疾病的表现，例如全身性红斑狼疮，血管炎，硬皮病和硬皮病 其他的;需要更有效地识别并招募患者进行临床研究，尤其是那些 罕见或罕见的疾病或临床表型；以及目前缺乏研究协调 跨正在进行的研究的基础设施，导致患者招聘，数据收集和数据效率低下 管理。 HSCP核心的创新包括利用强大的现有临床信息 基础设施弥合大量积累临床数据与个人之间的鸿沟 对风湿病的特定临床表型感兴趣的研究者；查询从 电子健康记录使用专业方法构建注册表；和之间的“搭配” 调查人员和资源。这些活动的总体目标是提供关键和最前沿 为进行人类受试者进行研究的研究人员创造规模经济的资源 风湿病。