The UNC Core Center for Clinical Research

北卡罗来纳大学临床研究核心中心

• 批准号: 10469652
• 负责人: LEIGH Fleming CALLAHAN
• 金额: $ 65.47万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-11 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10469652
• 关键词: Address; Adult; Aging; American; Area; Arthritis; Chronic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Communities; Data; Data Set; Databases; Degenerative polyarthritis; Development; Disease; Disease Progression; Elderly; Evaluation; Goals; Individual; International; Leadership; Lupus; Methodology; Musculoskeletal Diseases; National Institute of Arthritis and Musculoskeletal and Skin Diseases; North Carolina; Obesity; Observational Study; Outcome; Pain; Patients; Persons; Phenotype; Population; Prevalence; Prevention strategy; Public Health; Research; Research Activity; Research Personnel; Resources; Rheumatism; Rheumatoid Arthritis; Services; Statistical Methods; Subgroup; Testing; Training; Universities; Vasculitis; Work; analytical method; autoimmune vasculitis; base; clinical care; clinical center; clinical implementation; clinical phenotype; design; disability; disorder subtype; epidemiologic data; experience; improved; improved functioning; innovation; loss of function; member; multidisciplinary; novel; pain reduction; precision medicine; psychosocial; success; therapy design

ABSTRACT – OVERALL The overall goal of the University of North Carolina at Chapel Hill (UNC) Core Center for Clinical Research (CCCR) is to enhance the design and conduct of clinical studies in Rheumatic and Musculoskeletal Diseases (RMDs) with a focus on osteoarthritis (OA), a particular strength of our research community. The pain and loss of function that results from arthritis, combined with its prevalence, make it a leading cause of disability. OA is the most common form of arthritis. Efforts are urgently needed to improve the management of people with OA, as well as the many other RMDs, to reduce pain, improve function and slow or stop disease progression. Like other chronic conditions, RMDs are not single diseases but rather heterogeneous conditions consisting of multiple phenotypes that differ in their underlying pathobiological mechanisms. If not taken into consideration, these phenotypic differences result in the testing of interventions designed to address specific mechanisms of action in the “wrong” patients. Therefore, successful treatments for RMDs need to be targeted to, and tested in, specific subgroups or subtypes that share distinct underlying pathobiological, psychosocial and pain mechanisms consistent with the goal of precision medicine. Understanding and incorporating information about these phenotypes in clinical observational studies and trials will be crucial to move the field forward and is a major goal of our CCCR. Importantly, this pursuit will address the NIAMS long- range plan for clinical research which emphasizes that, “clinical characterization of disease subtypes is critical to assessment of epidemiological data and efficient design of clinical trials in these disease areas.” The proposed UNC CCCR will build on our transformative Multidisciplinary Clinical Research Center (MCRC), Mitigating the Public Health Impact of OA. Although the CCCR will have a focus on OA, the analytical methods used for phenotyping and precision medicine will also be applied to other RMDs that are strengths within our research community including RA, lupus, and vasculitis. Our goal is to optimize the design, analysis and implementation of clinical studies and trials in OA and other RMDs to advance clinical care and public health efforts targeted toward individuals with these conditions through the following aims: 1) Administrative Core: Provide leadership, oversight, coordination, evaluation, and general administrative support for all CCCR activities; 2) Methodology Core: Provide a comprehensive and integrated set of RMD-focused services to optimize the quality, efficiency and innovation of the CCCR research community that includes local, national and international members; 3) Phenotyping and Precision Medicine Resource Core: Provide services that will add value to and optimize the design and implementation of clinical studies as well as develop innovative strategies to maximize the use and success of clinical phenotyping and precision medicine in RMDs, with a focus on OA.

摘要 - 总体 北卡罗来纳大学教堂山（UNC）临床核心中心的总体目标 研究（CCCR）是为了增强风湿性和 肌肉骨骼疾病（RMD），重点是骨关节炎（OA），这是我们的特殊强度 研究社区。关节炎引起的疼痛和功能丧失，结合其患病率， 使其成为残疾的主要原因。 OA是关节炎的最常见形式。迫切需要努力 改善OA和许多其他RMD的人的管理，以减轻疼痛，改善 功能和缓慢或停止疾病进展。 像其他慢性病一样，RMD不是单一疾病，而是异质性疾病 由多种表型组成，其潜在的病理生物学机制不同。如果没有 考虑因素，这些表型差异导致测试旨在解决特定的干预措施 “错误”患者的作用机制。因此，需要针对RMD的成功治疗 进行并测试的特定亚组或子类型，它们具有不同的基础病理，心理社会心理 和疼痛机制与精确医学的目标一致。理解和编码 在临床检查研究和试验中有关这些表型的信息对于移动至关重要 该领域向前发展，是我们CCCR的主要目标。重要的是，这种追求将解决尼亚姆人长期解决 临床研究的范围计划，强调：“疾病亚型的临床表征至关重要 评估流行病学数据和这些疾病地区临床试验的有效设计。” 拟议的UNC CCCR将在我们的变革性多学科临床研究中心建立 （MCRC），减轻OA的公共卫生影响。尽管CCCR将专注于OA，但分析性 用于表型和精确药物的方法也将应用于其他RMD，这是优势 在我们的研究社区中，包括RA，狼疮和血管炎。我们的目标是优化设计， OA和其他RMD中的临床研究和试验的分析和实施，以推进临床 通过以下 目的：1）行政核心：提供领导，监督，协调，评估和一般 所有CCCR活动的行政支持； 2）方法论核心：提供全面而综合的 一套以RMD为中心的服务，以优化CCCR研究的质量，效率和创新 包括地方，国家和国际成员的社区； 3）表型和精密医学 资源核心：提供将为临床的设计和实施增加价值的服务 研究以及制定创新策略，以最大化临床表型的使用和成功 RMD中的精密医学，重点是OA。