The UNC Core Center for Clinical Research: Methodologic Core

抽象-方法论核心 风湿性和肌肉骨骼疾病(RMD)，包括骨关节炎(OA)，是疼痛和 世界范围内的残疾，但在我们对疾病机制和最佳 许多RMD的治疗策略。迫切需要高质量的高级学习，这将 有意义地提高我们对RMD的理解，特别是预测疾病进展的表型 和治疗反应。我们北卡罗来纳大学(UNC)核心中心的方法学核心 临床研究(CCCR)独一无二地配备了一套全面的资源，将 优化地方、国家和国际的RMD临床研究。我们的方法核心包括 在生物统计学和生物信息学、流行病学研究、临床试验、培训方面有专长的研究人员 和辅导、健康差距、干预措施的制定、传播和实施，以及 RMD在成像、生物标记物和治疗指南等领域的特定专业知识。我们有一个很长的， 设计和实施开创性临床RMD研究(特别是在骨性关节炎方面)的成功记录； 将初级调查人员培养成独立的研究人员，促进国家/国际合作， 向RMD研究界提供方法学培训，领导国内和国际RMD- 有重点的工作小组以及沟通、倡导和影响公共政策。在基础上建设和扩展 我们成熟的流程和成熟的基础设施，方法论核心将继续为RMD服务 通过实现三个具体目标来研究社区。第一，支持发展和应用 先进和创新的统计方法(例如，监督和非监督机器学习， 结果加权学习、马尔可夫状态建模、高维低样本量方法、异质性 治疗效果)到临床RMD研究；这将包括对我们的表型和精度的支持 医学核心。第二，我们将提供全面、严谨的多学科方法资源 支持和推进CCCR基础内的临床RMD研究，以及通过合作努力 地方、国家和国际。第三，我们将提供最先进的教育材料和培训 使本地和国内/国际的研究人员做好准备，进行高质量的创新临床 关于RMD的研究。总的来说，这些AIMS将为大型的国际临床RMD研究提供服务 社区，导致研究显著改善了许多人的护理和结果 患有RMD的患者。

ABSTRACT – METHODOLOGY CORE Rheumatic and musculoskeletal diseases (RMDs), including osteoarthritis (OA), are major sources of pain and disability worldwide, yet significant gaps persist in our understanding of disease mechanisms and optimal treatment strategies for many RMDs. There is a critical need for high quality, advanced studies that will meaningfully improve our understanding of RMDs, particularly phenotypes that predict disease progression and treatment response. The Methodology Core of our University of North Carolina (UNC) Core Center for Clinical Research (CCCR) is uniquely equipped to provide a comprehensive suite of resources that will optimize clinical RMD studies locally, nationally and internationally. Our Methodology Core includes researchers with expertise in biostatistics and bioinformatics, epidemiological studies, clinical trials, training and mentoring, health disparities, intervention development, dissemination and implementation, along with RMD-specific expertise in areas including imaging, biomarkers, and treatment guidelines. We have a long, successful track record of designing and conducting seminal clinical RMD studies (particularly in OA), developing junior investigators into independent researchers, fostering national/international collaborations, delivering methodological training to the RMD research community, leading national and international RMD- focused work groups and communicating, advocating, and influencing public policy. Building and expanding on our proven processes and established infrastructure, the Methodology Core will continue to serve the RMD research community by achieving three specific aims. First, we will support the development and application of advanced and innovative statistical methodologies (e.g., supervised and unsupervised machine learning, outcome-weighted learning, Markov state modeling, high dimensional low sample size methods, heterogeneity of treatment effects) to clinical RMD studies; this will include support for our Phenotyping and Precision Medicine Core. Second, we will provide comprehensive, rigorous multidisciplinary methodological resources that support and advance clinical RMD research within the CCCR base, as well as through collaborative efforts locally, nationally and internationally. Third, we will deliver state-of-the-art educational materials and training that prepare researchers, both locally and nationally/internationally, to conduct high quality, innovative clinical studies on RMDs. Collectively, these aims will provide services to a large, international clinical RMD research community, resulting in studies that lead to significant improvements in care and outcomes for the many patients living with RMDs.