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.