Real World Evidence
The explosion in patient-generated data and advancements in technology provide unprecedented opportunities for improving patient care.
Patient-generated data holds great promise for the future of every phase of clinical research, helping to usher in a new era of pragmatic clinical trials. Data collected from “real-world” patients can improve trial design, aid trial participant recruitment, help to generalize research findings to broader populations, and provide a clearer picture of how therapeutic interventions work outside of the research setting. Yet, along with these opportunities, comes unique challenges. How do we shift real-world evidence beyond its most accepted use in post-approval surveillance models to use in pre-approval phase to streamline clinical trials? How do we use patient-generated data to help guide policy decisions and improve the drug and device approval process?
Through its collaboration with PCORnet, the NIH Health Care Systems Research Collaboratory, The Robert J. Margolis Center for Health Policy, and others, the DCRI is working to gain and share knowledge about how real-world evidence can make pragmatic trials a powerful tool for evidence generation.
Lesley Curtis, PhDDirector, Data Solutions for Health Services Research
"How do we use data captured from the actual experiences of patients during routine patient care to strengthen the evidence base for the approval, safety, and effectiveness of drugs?"
A New Approach to Real-World Evidence
The Duke-Margolis Center for Health Policy has issued a white paper, authored by the DCRI's Adrian Hernandez, MD, MHS, and others, suggesting a new framework for the use of real-world evidence in clinical research.
Statin Dosing Patterns and the PALM Registry
The Patient and Provider Assessment of Lipid Management (PALM) registry enrolled more than 7,900 patients across the United States to determine if they were receiving guideline-recommended doses of statins for high cholesterol.
DCRI Partners with Datavant to Change Clinical Research
The DCRI will be working with Datavant, a healthcare technology company, to accelerate data-driven approaches in drug development and facilitate rapid scaling of best practices in clinical research.
Collaboration: The Duke-Margolis
Center for Health Policy
The DCRI is partnering with the Duke-Margolis Center for Health Policy to coordinate resources across Duke and change how scientific discoveries inform policymaking. With the Center for Population Health Sciences, the DCRI and Duke-Margolis are actively pursuing acquisition of Center for Medicare and Medicaid Services claims data that will enable faculty to investigate longitudinal outcomes for questions on clinical outcomes, population health measures, and measures of value and accountable care. Together, the centers are developing outreach, documentation, and governance to maximize access and maintain the highest levels of research integrity and academic productivity.
Adrian Hernandez, MD, MHS
Director, Health Services and Outcomes Research
Adrian Hernandez, MD, MHS, is a cardiologist with extensive experience in clinical research ranging from clinical trials to outcomes and health services research. He is the Director of Health Services and Outcomes Research and a Faculty Associate Director of the DCRI. He leads research programs focused on understanding population health, generating real-world evidence, and improving patient-centered outcomes through development of new therapies and better care delivery in our national health system.
He is the Coordinating Center Principal Investigator for multiple networks and clinical trials such as the NHLBI’s Heart Failure Clinical Research Network, PCORI’s National Patient-Centered Clinical Research Network (PCORnet) and NIH’s Health System Collaboratory.