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?"
Hernandez Shares Real-World Evidence Insights at Bipartisan Policy Center Panel
The DCRI's Director of Health Services and Outcomes Research Adrian Hernandez, MD, MHS, was invited to participate in a Bipartisan Policy Center roundtable focused on advancing the generation and use of real-world evidence.
Temporal Trends and Factors Associated With Cardiac Rehabilitation Referral Among Patients Hospitalized With Heart Failure: Findings From Get With The Guidelines-Heart Failure Registry
Current guidelines recommend cardiac rehabilitation in medically stable outpatients with heart failure. However, temporal trends and factors associated with cardiac rehabilitation referral among these patients in real-world practice are not entirely known.
DCRI’s Duke Evidence Synthesis Group to collaborate with FDA Payer Communication Task Force
The Duke Evidence Synthesis Group has been invited to join a new effort from the FDA’s Center for Devices and Radiological Health designed to provide medical device manufacturers an opportunity to obtain private payer input on clinical trial design or other plans for gathering clinical evidence needed to support positive coverage decisions.
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 of Health Services and Outcomes Research
“Real-world evidence complements traditional randomized clinical trials of select populations to help us understand how a new drug or treatment could be beneficial in other populations or for other indications. These insights make it easier for patients to make the right healthcare decisions and for clinicians to better understand the benefit/risk profile of treatments they prescribe.”