Vanderbilt University Medical Center has received an 18-month, $6.9 million award to set up a Clinical Data Research Network (CDRN) that can reach millions of patients and speed the translation of research findings into clinical practice.
Vanderbilt’s award will establish the Mid-South CDRN. It is one of 11 such awards recently announced by the Patient-Centered Outcomes Research Institute (PCORI), an independent, non-profit organization authorized by Congress in 2010 to fund research aimed at improving the health of entire populations.
The 11 CDRNs will join 18 “Patient-Powered” Research Networks governed by patient and provider groups to form a National Patient-Centered Clinical Research Network called PCORnet.
The idea is to “change the paradigm” of clinical research with the help of electronic health records (EHRs), information technology and robust research support infrastructure,” said Russell Rothman, M.D., MPP, principal investigator of the Mid-South CDRN and director of the Vanderbilt Center for Health Services Research.
“This network is going to help us to improve how we deliver health care in this country, improve the quality of care that patients and families receive and allow us to rapidly and efficiently answer a lot of big questions that address patients’ real needs,” Rothman said.
Rothman’s co-principal investigators are Trent Rosenbloom, M.D., MPH, and Paul Harris, Ph.D., associate professors of Biomedical Informatics who have been deeply involved in the development of some of the informatics tools to be used by the CDRN.
“We are excited to connect several large clinical networks from the Southeast and across the country,” Rosenbloom said. “This will allow us to conduct large patient-centered outcomes research on participants of all ages.”
Traditional clinical trials have been limited by cost to following several hundred or a few thousand patients for a few months to a few years. PCORnet will follow millions of patients for a much longer period of time using mechanisms that ensure data security and maintain patient privacy.
Participants will be able to report from home or other locations about how they’re doing, and the huge number of people in the national network will make is easier for researchers to study rare diseases. The overall aim is to bring treatment advances into clinical care more quickly.
Initially, the Mid-South CDRN will recruit three cohorts of research subjects:
• 10,000 individuals for a study of weight-related health issues led by Rothman, associate professor of Medicine and Pediatrics, and which will be conducted by each of the CDRNs.
• 10,000 individuals with coronary heart disease led by Sunil Kripalani, M.D., M.Sc., associate professor of Medicine.
• 400 families affected by sickle cell disease, for a study of a rare condition led by Michael DeBaun, M.D., MPH, the J.C. Peterson, M.D. Professor of Pediatric Pulmonology and director of the Vanderbilt-Meharry-Matthew Walker Center for Excellence in Sickle Cell Disease.
The Mid-South CDRN will have access to data from three patient groups:
• More than 2 million patient records in the Vanderbilt Health System.
• An estimated 3 million to 4 million patients who are expected to be in the rapidly growing Vanderbilt Health Affiliated Network (VHAN), which currently includes approximately 40 hospitals and up to 500 clinical practices in Tennessee and six surrounding states.
• Through a partnership with a leading EHR provider, Greenway Medical Technologies Inc., about 24 million patients nationwide.
“This important clinical research network significantly adds to our capability to develop, examine and improve population health management, a critical feature of the future of health care delivery and an essential core asset for VHAN,” said Robert Dittus, M.D., MPH, associate vice chancellor for Public Health and Health Care.
Dittus, the Albert and Bernard Werthan Professor of Medicine, also directs the Institute for Medicine and Public Health and is senior associate dean for Population Health Sciences.
The CDRN award is one of several given to Vanderbilt researchers by PCORI in the past several months to support patient-centered comparative clinical effectiveness and outcomes research.
“Vanderbilt is in a unique position nationally to leverage these awards and boost our ongoing efforts to personalize medicine for our patients,” said Gordon Bernard, M.D., the Melinda Owen Bass Professor of Medicine, associate vice chancellor for Research and director of the Vanderbilt Institute for Clinical and Translational Research.
