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: 10017000
• 负责人: LEIGH Fleming CALLAHAN
• 金额: $ 67.24万
• 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/10017000
• 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; 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分校 (UNC) 临床核心中心的总体目标 研究 (CCCR) 旨在加强风湿病和风湿病临床研究的设计和实施 肌肉骨骼疾病 (RMD)，重点关注骨关节炎 (OA)，这是我们的特殊优势 研究社区。关节炎引起的疼痛和功能丧失，加上其患病率， 使其成为残疾的主要原因。 OA 是最常见的关节炎形式。迫切需要努力 改善对 OA 以及许多其他 RMD 患者的管理，以减轻疼痛、改善 功能并减缓或阻止疾病进展。 与其他慢性病一样，RMD 不是单一疾病，而是异质性疾病 由其潜在病理生物学机制不同的多种表型组成。如果没有纳入 考虑到这些表型差异导致对旨在解决特定问题的干预措施进行测试 “错误”患者的作用机制。因此，成功治疗 RMD 需要有针对性 并在特定的亚组或亚型中进行测试，这些亚组或亚型具有不同的潜在病理生物学、心理社会学特征 和疼痛机制符合精准医学的目标。理解并融入 临床观察研究和试验中有关这些表型的信息对于移动至关重要 领域向前发展，是我们 CCCR 的一个主要目标。重要的是，这一追求将解决 NIAMS 长期以来的问题 临床研究范围计划强调，“疾病亚型的临床特征至关重要 评估这些疾病领域的流行病学数据和有效设计临床试验。” 拟议的 UNC CCCR 将建立在我们变革性的多学科临床研究中心的基础上 (MCRC)，减轻 OA 对公共健康的影响。尽管 CCCR 将重点关注 OA，但分析 用于表型分析和精准医学的方法也将应用于其他具有优势的 RMD 我们的研究界包括 RA、狼疮和血管炎。我们的目标是优化设计， 分析和实施 OA 和其他 RMD 的临床研究和试验，以推进临床 通过以下方式针对患有这些疾病的个人进行护理和公共卫生工作 目标： 1) 行政核心：提供领导、监督、协调、评估和一般性 对所有 CCCR 活动的行政支持； 2）方法论核心：提供全面、综合的方法论 一套以 RMD 为中心的服务，旨在优化 CCCR 研究的质量、效率和创新 包括当地、国家和国际成员的社区； 3）表型分析和精准医学 资源核心：提供能够增加价值并优化临床设计和实施的服务 研究并制定创新策略，以最大限度地利用临床表型分析并取得成功 RMD 中的精准医疗，重点是 OA。