The UNC Core Center for Clinical Research

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)是为了加强风湿性和风湿性疾病临床研究的设计和进行 肌肉骨骼疾病(RMD)，重点是骨关节炎(OA)，这是我们 研究社区。关节炎引起的疼痛和功能丧失，再加上它的流行， 使其成为导致残疾的主要原因。骨性关节炎是最常见的关节炎。迫切需要努力 改善对OA患者以及许多其他RMD的管理，以减少痛苦，提高 起作用并延缓或阻止疾病的进展。 像其他慢性疾病一样，RMD不是单一的疾病，而是各种疾病 由多种表型组成，这些表型在潜在的病理生物学机制上有所不同。如果不被纳入 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，RMD的成功治疗需要有针对性。 在特定的亚群或亚型中进行测试，这些亚群或亚型具有不同的潜在病理生物学、心理社会 疼痛机制与精准医学的目标一致。理解和融入 在临床观察研究和试验中关于这些表型的信息将是至关重要的 球场前锋，这是我们CCCR的一个主要目标。重要的是，这一追求将解决NIAMS的长期- 临床研究的范围计划，强调“疾病亚型的临床特征至关重要 以评估流行病学数据和有效设计这些疾病领域的临床试验。“ 拟议的北卡罗来纳大学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将重点放在办公自动化上，但分析性的 用于表型鉴定和精确医学的方法也将应用于其他有优势的RMD 在我们的研究社区内，包括类风湿性关节炎、狼疮和血管炎。我们的目标是优化设计， 分析和实施骨关节炎和其他RMD的临床研究和试验，以促进临床 通过以下方式为患有这些疾病的个人提供护理和公共卫生努力 目标：1)行政核心：提供领导、监督、协调、评估和一般 为CCCR的所有活动提供行政支持；2)方法核心：提供全面和综合的 一套以RMD为重点的服务，以优化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)表型和精密医学 资源核心：提供将为临床设计和实施增值并优化其设计和实施的服务 研究以及开发创新战略，以最大限度地利用和成功地使用临床表型和 RMD中的精准医学，重点是OA。

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.