Real-World Evidence

Real-World Evidence

The explosion in patient-generated data and advancements in technology provide unprecedented opportunities for improving patient care.

Our Thinking

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 H. Curtis, PhD
Chair and Professor,
Department of Population Health Sciences

"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?"



Cerner logoPartnering to Build a Research Network


The DCRI is partnering with Cerner, the world's largest electronic health record company, to conduct clinical research using Cerner's cloud-based platform.

FDA's Framework for Real-World Evidence Program

Helping the FDA Advance Its Strategy for Use of Real-World Evidence


Through its many projects and collaborations that relate to real-world evidence, the DCRI is helping deliver insights on best practices. Some of these insights were incorporated into the FDA's new Framework for Real-World Evidence.

Logo for ASCEND trial

Shedding New Light on Trial Enrollment


Stephen Greene, MD, and Robert Mentz, MD, used real-world data from a registry to find that minority populations enrolled in heart failure trials may be not be representative of real-world populations.

Incorporating Real-World Evidence in Clinical Research

Brad Hammill, DrPH, discusses how the DCRI is leveraging new real-world data sources to conduct health services research. He explains that the way data was traditionally collected for clinical trials is changing, and how essential it is for researchers to learn how to utilize real-world data sources moving forward. This includes the best methods for incorporating real-world data and setting the standards necessary to do it responsibly.

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 an 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.


DCRI Real-World Evidence Thought Leadership

Adrian Hernandez, MD, MHS

Executive Director, Duke Clinical Research Institute

Vice Dean, Duke University School of Medicine

Adrian Hernandez, MD, MHSAdrian Hernandez is a cardiologist with extensive experience in clinical research ranging from clinical trials to outcomes and health services research. He is the Vice Dean for Clinical Research at Duke University School of Medicine 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 the 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.