A Broad-Based and Deep Bench of Expertise Provided By Leading Scientists and Thought Leaders

Purpose

Todd Schwartz, DrPH; and Kelli Allen, PhD, Co-Directors of the Methodology Core

The Methodology Core serves as the foundation of the UNC Core Center for Clinical Research (CCCR), and provides key support for the development and implementation of innovative clinical studies in rheumatological and musculoskeletal diseases (RMDs). Osteoarthritis (OA), a historical strength of our research community, affects an estimated 30.8 million Americans, and its prevalence is expected to increase substantially. However, significant gaps persist in our understanding of disease mechanisms and optimal treatment strategies for OA and other RMDs.

Therefore, there is a critical need for high quality, advanced studies to improve our understanding of RMDs, particularly of specific phenotypes that predict disease progression and treatment response. Solving these complex problems requires pairing experts in RMD content areas with proficient methodologists with a deep understanding of the key issues surrounding clinical studies in these disease areas.

A Proven Team, With a Track Record of Success

Our Methodology Core includes researchers with in-depth expertise in:

  • Biostatistics & Bioinformatics
  • Epidemiological Studies and Clinical Trials
  • Study Logistics, Dissemination and Implementation
  • Imaging, Biomarkers, Health Disparities
  • Intervention development, Clinical Aspects of RMDs, and Education

This well-established team has a long, successful track record of designing and conducting seminal clinical studies with an emphasis on OA, fostering national/international collaborations, leading national and international work groups, and influencing public policy. Our collective expertise uniquely positions us to continue serving the RMD research community with a comprehensive suite of services that will synergize and add value to studies conducted by researchers locally, nationally and internationally.

A Vast Depth and Breadth of Expertise, Keenly Focused on Your Needs

The CCCR Methodology Core, building on proven processes and infrastructure already established in our Multidisciplinary Clinical Research Center, will partner with RMD researchers to support optimized design and efficiency in clinical studies.

The Methodology Core will facilitate optimized design of studies through our expertise in:

  • Advanced statistical methods (including machine learning and big data methods, in collaboration with the Phenotyping and Precision Medicine Resource Core)
  • Innovative trial designs
  • Complex longitudinal epidemiological methods
  • Advanced imaging analysis

The Methodology Core will promote efficiency by providing RMD researchers with an infrastructure and expertise in essential aspects of study development and conduct, including:

  • Recruitment processes and patient selection criteria
  • Intervention development
  • Stakeholder engagement

The Methodology Core will continue to provide these services locally (through collaborations in multiple Schools, Departments and Centers at UNC), as well as nationally and internationally through key RMD organizations.

The Methodology Core’s Aims:

  • Support the development and application of advanced and innovative statistical methodologies (machine learning, outcome-weighted learning, Markov state modeling, high dimensional low sample size methods, heterogeneity of treatment effects) to clinical RMD studies.
    • a. Provide expertise and support for the selection and application of appropriate, advanced statistical methods to the UNC CCCR community. These statistical services are provided through all phases (development through dissemination) of RMD epidemiological studies and trials, with the ultimate goal of optimizing & personalizing RMDcare.
    • b. Support the activities of our CCCR’s Phenotyping and Precision Medicine Resource Core. This includes providing expertise on the application of machine learning and other advanced statistical methodologies, as well as completion of foundational tasks such as data harmonization.
  • 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/internationally. Services are delivered via an established and highly effective infrastructure that includes collaborative and individual consultations and leverages key resources at UNC. Services will span all phases and aspects of clinical RMD research, from study development through dissemination.
  • 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. We will leverage the extensive resources and expertise in education and dissemination at the Thurston Arthritis Research Center, the UNC School of Medicine, the Osteoarthritis Action Alliance and local and national professional partnerships to provide training opportunities that focus on optimized design of RMD studies, with an emphasis on advanced statistical methodologies.

For more information, or to speak with someone regarding our Methodology Core, please contact:  Todd Schwartz, DrPH; tschwart@email.unc.edu, or Kelli Allen, PhD; kdallen@email.unc.edu.

To initiate the process of requesting information, consultation, collaboration, and/or data from UNC’s CCCR, please complete and submit this form.