In its 50-year history, the Collaborative Studies Coordinating Center at the University of North Carolina at Chapel Hill has coordinated activities for over 40 large, multi-site clinical trials and epidemiology studies. These studies have involved hundreds of clinical or field centers and hundreds of thousands of research subjects and produced over 2,000 research publications.
The CSCC consists of more than 100 staff and students, including more than a dozen faculty members from the UNC - Chapel Hill departments of Biostatistics, Epidemiology, Nutrition, Medicine (Cardiology Division) and Social Medicine. People at the center collaborate with co-investigators in numerous other departments, centers, and schools across the UNC - Chapel Hill campus.
The CSCC has a distinguished history as a pioneer in clinical data management. In 1971, the National Heart, Lung, and Blood Institute (NHLBI), at the National Institutes of Health (NIH), awarded the Lipid Research Clinics Program (LRC) coordinating center to the UNC - Chapel Hill Department of Biostatistics. The LRC was funded for 19 years, making it one of the longest running studies funded by the NIH.
The center was the first NIH coordinating center to implement remote data entry on a national project in 1986, followed by a web-based data management system in 2001. In 2010, the CSCC introduced its next generation data management system, CDART (Carolina Data Acquisition & Reporting Technology). It was created with help from the North Carolina Translational and Clinical Sciences Institute and was jointly funded by the CSCC and the UNC - Chapel Hill School of Medicine Clinical and Translational Science Award (CTSA) grant.
CDART is an FDA 21 Part 11 compliant data management system for use in large multi-center clinical trials and observational studies. CDART provides an interactive web interface with real-time field validation, audit logs to record database modifications, strict data integrity checks and integrated reports, and protocol-specific adaptive randomization procedures. CDART has been used by 20 multi-center studies at over 150 clinical sites and has recorded data for over 80,000 study participants. See more about CDART here.
In 2020, the CSCC developed a secure research Data Portal. The cloud-based central data repository and computing infrastructure is hosted in Microsoft Azure for researchers to access and conduct analysis on various types of data.
CSCC projects span the clinical areas of cardiovascular and cerebrovascular disease, chronic lung disease, nutrition and obesity, periodontal disease, kidney disease, mental health, and child health.
The longest running active CSCC project is the Atherosclerosis Risk in Communities (ARIC) Study, begun in 1986 with continuing follow-up of a cohort of over 15,000 individuals.
Another hallmark project is the Hispanic Community Health Study/Study of Latinos (HCHS/SOL), a prospective epidemiological study of 16,000 Hispanics living in the U.S. It is designed to evaluate the relationship between baseline risk factors such as acculturation, environmental exposures, diet, and exercise with health outcomes that include both cardiovascular and pulmonary endpoints for this fast-growing minority population.
The CSCC was awarded the coordinating center role for the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN), a large research program aiming to defeat the rising HIV epidemic among adolescents and young adults in the United States.
The Helping to End Addiction Long-termsm Initiative, or NIH Heal Initiativesm, is focused on improving prevention and treatment strategies for opioid misuse and addiction, and enhancing pain management. The initiative funded the CSCC for the Back Pain Consortium Research Program (BACPAC). The BACPAC consortium is made up of 13 individual research projects across the US conducting research on chronic low back pain. The CSCC serves as the coordinating center for all 13 BACPAC projects, while planning and overseeing a large multi-site clinical trial for chronic low back pain. The CSCC created and maintains the data repository and data standardization guidelines for all data from the individual projects and the clinical trial.
Details on these and other studies, past and present, can be found on the Projects page.
CSCC Director Timeline
The center began operations under the leadership of James E. Grizzle, who went on to become the chairperson for the UNC - Chapel Hill Department of Biostatistics.
The center was led under the directorship of O. Dale Williams, PhD, and C.E. Davis, PhD, as deputy director.
After Dr. Williams moved to Birmingham, Alabama in 1991, Dr. Davis led the Coordinating Center as Director until late in 1997, when he became Chair of the UNC - Chapel Hill Department of Biostatistics.
Lloyd E. Chambless, PhD, took over as the interim Director and was named Director in 2000. Dr. Chambless stepped down in 2005 to devote more time to his active studies.
Lisa M. LaVange, PhD, led the Center from 2005 to 2011. She departed to be a Director of the Office of Biostatistics in the Office of Translational Sciences at the US Food and Drug Administration (FDA).
In 2012, Sonia Davis, DrPH, came from Quintiles to direct the center for five years. In 2017, Dr. Davis returned to pharmaceutical work at RTI. From 2017 - 2018, the center was led by Dr. Davis, who returned to serve as interim director.
The CSCC returned to the leadership of Dr. Lisa LaVange in 2018. Dr. LaVange became the Chair of the UNC - Chapel Hill Department of Biostatistics in 2021. David Couper, PhD, served as the interim center director.
In February 2022, Kevin Anstrom, PhD, MS, joined UNC - Chapel Hill as the director of the CSCC and as Professor of Biostatistics. Dr. Anstrom’s qualifications include 25 years in a coordinating center environment and his experience as a Principal Investigator for several clinical networks and trials.