The genomic revolution is upon us. The question is, how can the explosion of new knowledge be used — now — to prevent and treat disease and improve health?
Researchers at Vanderbilt University Medical Center believe the answer may involve a “learning” network that, by assessing the impact of genomic data and clinical informatics on medical practice, can demonstrate the power of precision medicine for doctors and patients.
This week the National Human Genome Research Institute, part of the National Institutes of Health, awarded two five-year grants totaling $12 million to support VUMC’s participation in, and coordination of, a genomic-enabled learning health system (gLHS) network.
VUMC is a pioneer in the development of learning health systems, which systematically integrate internal data and experience with external evidence and apply that knowledge to clinical practice to improve population health.
“This new network of learning health systems will generate high-quality, practice-changing evidence for genomics using techniques pioneered at VUMC,”said Josh Peterson, MD, MPH, professor of Biomedical Informatics and Medicine, director of the Center for Precision Medicine, and VUMC Vice President for Personalized Medicine.
Peterson is co-principal investigator of the coordinating center grant with Wesley Self, MD, MPH, Senior Vice President for Clinical Research and director of the Vanderbilt Institute for Clinical and Translational Research (VICTR), and Carolyn Audet, PhD, associate professor of Health Policy and co-director of the Center for Clinical Quality and Implementation Research. Self holds the Directorship in Emergency Care Research.
Co-PIs of the clinical site grant are Alexander Bick, MD, PhD, assistant professor of Medicine, Dan Roden, MD, the Sam L. Clark, MD, PhD Chair and Senior Vice President for Personalized Medicine, and Sunil Kripalani, MD, MSc, professor of Medicine and Health Policy, and Vice President for Health System Sciences.
“In this new network, we look forward to using implementation science to speed the translation of genomic discoveries into practice as part of our broader learning health system efforts,” said Kripalani, who has helped advance the design, implementation and evaluation of clinical quality improvement strategies.
A real-world LHS was established at VUMC a decade ago. Since then, 34 randomized controlled clinical trials enrolling more than 50,000 patients have been completed, leading to changes in clinical practice guidelines and improved care internationally.
Multiple initiatives have applied genomic testing to clinical practice. In 2010, for example, VUMC launched its preemptive pharmacogenetic testing program, called PREDICT, which screens patients for genetic variations that increase their risk of reacting adversely to certain drugs.
As a clinical site, VUMC will partner with the University of Miami Hospital and Clinics to focus efforts on diverse settings and underserved populations. Potential projects include:
- Integrating family health histories into the electronic health record (EHR) and evaluating longitudinal clinical data to improve early diagnosis of familial cancer syndromes and cardiovascular disease, and to identify patients who might have an undiagnosed genetic disease.
- Implementing personalized genomic reference ranges for common laboratory tests to improve diagnostic accuracy and health equity.
“Our genomic learning health system will enable us to identify more patients who would benefit from using genomics to make their health care personal,” said Bick, a leader in genetic medicine.
The coordinating center, which is called DRAGON, for the Demonstrating Realworld Advancement in Genomics Operations Network, will include:
- A Genomic Operations Unit, which will coordinate all network activities.
- A Study Design and Outcomes Unit, which will work with the clinical sites to select and optimize network projects.
- A Data and Informatics Unit, which will serve as a central hub for standardizing and measuring outcomes from genomic medicine interventions.
- An Engagement Unit, which will promote communication and trust among patients, families and communities, as well as payors, providers and health systems.
“VUMC has been at the forefront of genomic discovery,” said Roden, a pioneer in pharmacogenomics and personalized medicine. “The challenge and the opportunity of this network is to develop approaches that will test how best to translate what we know to improve the way we care for patients.”
