Real-World Evidence
As thought leaders in RWE, Duke-Margolis engages public and private stakeholders in this burgeoning field. Read on to find the publications, projects, news, and contact information of our real-world evidence team.
Projects Relating to Real-World Evidence
Randomized controlled trials (RCTs) are traditionally used by the US Food and Drug Administration (FDA) to evaluate a product’s safety and effectiveness. While they are the gold-standard from a research perspective, RCTs are resource-intensive and require investing significant financial, time, and human capital. Coupled with unmet clinical needs and drug-access challenges, the demands of RCTs have fueled a call to action from patients and legislators. The regulatory system needs new ways to optimize the drug development process, so the delivery of effective drugs to the marketplace accelerates—while public safety remains ensured.
A large amount of patient information is captured at the point of care. Health care stakeholders are enthusiastic to explore whether that information can inform and hasten new drug development. Called real-world data (RWD), analyzing this burgeoning data source has the potential to provide real-world evidence (RWE). In turn, that RWE can tell us about the use of drugs, drug outcomes, and it can help us understand whether drugs are performing as intended in routine care.
Duke-Margolis Faculty & Research Team
Nancy Allen LaPointe
Faculty Fellow, Duke-Margolis Center for Health Policy
Adjunct Associate Professor in the Department of Medicine Faculty
Margolis Core Faculty
Adam Aten, MPH, MSc
Assistant Research Director
Laura Benzing
2020 Margolis Intern
Hayden Bosworth, PhD
Professor in Population Health Sciences
Margolis Affiliated Faculty
Matt D'Ambrosio
Policy Research Assistant
Nora Emmott
Senior Policy Analyst
Mira Gill, MS
Policy Analyst
Tong Guo, PhD
Margolis Affiliated Faculty
Assistant Professor in Marketing
Appointment in Department of Economics
Rachele Hendricks-Sturrup, DHSc, MSc, MA
Research Director
Senior Team Member
Trevan Locke, PhD
Assistant Research Director
Herbert Kim Lyerly, MD
George Barth Geller Distinguished Professor of Surgery
Margolis Core Faculty
Mark McClellan, MD, PhD
Director of Margolis Center
Robert J. Margolis, MD, Professor of Business, Medicine and Policy
Margolis Executive Core Faculty
Maryam Nafie
Policy Research Assistant
Morgan Romine, MPA
Chief of Staff
Senior Team Member
Christina Silcox, PhD
Research Director, Digital Health
Adjunct Assistant Professor
Senior Team Member
Margolis Core Faculty
News Update January 9, 2020
New Evidence Approach Recommended to Evaluate Medical Product Effectiveness
Including real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making could...
Read MorePress Release September 27, 2019
Press Release: Evaluating Real-World Data Reliability for Drug Development and Regulation
Washington, DC—In a new paper, the Duke-Margolis Center for Health Policy provides a systematic...
Read MoreNews Update August 21, 2019
New BPC Report Calls for Expanded Use of Real-World Evidence for Decision-Making on Drugs and Biologics
Washington, D.C. — Today, the amount of electronic health care data is rapidly growing due to the...
Read More
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Biomedical Innovation
Duke-Margolis, in partnership with FDA and a wide array of other stakeholder groups, is focused on…
