UNC Core Center for Clinical Research

OVERALL CCCR ABSTRACT The overall goal of the UNC 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. Unfortunately, RMDs remain a major burden to patients and society. Many RMDs are rare, and even those that are common, such as OA, are so heterogeneous that no effective therapies have yet been identified. Improved understanding of phenotypes within RMDs, and individualized management targeted to these groups, is needed to improve the health of our patients. Understanding and incorporating phenotypic information 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 renewal UNC CCCR will build on the current, transformative CCCR which has had a major impact on OA phenotyping and precision medicine research. Although the CCCR will maintain its focus on OA, the analytical methods used for phenotyping and precision medicine are readily applicable to other RMDs that are strengths within our research community including RA, back pain, lupus, and myositis. 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 suite of state-of- the-art resources 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: Develop and characterize a new, high value, real-world data resource while continuing to provide consultative services around phenotyping and precision medicine analyses and training/educational opportunities in data science. The combined and integrated activities proposed in the three cores combined with the extensive and successful research community, make for a Center that truly is greater than the sum of its individual parts. This CCCR will provide a unique resource to benefit those working in RMD research but ultimately all those who have or might develop RMDs.