Real-World Evidence
Projects Relating to Real-World Evidence
Duke-Margolis Faculty & Research Team

Adam Aten, MPH, MSc
Research Associate

Laura Benzing
2020 Margolis Intern

Joy Eckert, MPH
Research Associate

Adam Kroetsch, MPP
Research Director, Biomedical Innovation and Regulatory Policy
Senior Team Member
Nirosha Mahendraratnam Lederer, PhD, MSPH
Managing Associate, Real World Evidence
Senior Team Member
2020 Intern Mentor

Mark McClellan, MD, PhD
Director of Margolis Center
Robert J. Margolis, MD, Professor of Business, Medicine and Policy
Margolis Executive Core Faculty

Kerra Mercon
Senior Research Assistant

Valerie Parker
Policy Analyst

Morgan Romine, MPA
Chief of Staff
Senior Team Member

Christina Silcox, PhD
Digital Health Policy Fellow
Adjunct Assistant Professor
Senior Team Member
Margolis Core Faculty

Kelly Wahl, MPH
Research Associate
Events About Real-World Evidence
More EventsEvent 2/16-2/17/2021
Evaluating RWE from Observational Studies in Regulatory Decision-Making: Lessons Learned from Trial Replication Analyses
Observational (non-interventional) studies—typically involving analyses of real-world data (RWD)…
Read MoreEvent 1/29/2021
An Introduction to Real-World Data & Real-World Evidence: A Virtual Training Series for the Patient Community
Have you been hearing about Real-World Evidence (RWE) and Real World Data (RWD) and wondering what…
Read MoreEvent 12/7/2020
Developing Study Endpoints in Real-World Settings
To advance the use of real-world data (RWD) and real-world evidence (RWE) for regulatory decision…
Read MoreEvent 2/13/2020
Public Webinar: Addressing Challenges in Payment and Access to Treatments for Early-Stage Alzheimer’s Disease
Alzheimer’s disease (AD) impacts a broad section of society, and while there are some treatments…
Read MorePublications About Real-World Evidence
More PublicationsWhite Paper
A Roadmap for Developing Study Endpoints in Real-World Settings
Kerra Mercon, Nirosha Mahendraratnam, Joy Eckert, Christina Silcox, Morgan Romine, Kathryn Lallinger, Adam Kroetsch, Huzyfa Fazili, Marta Wosińska, Mark McClellan
Kerra Mercon, Nirosha Mahendraratnam, Joy Eckert, Christina Silcox, Morgan Romine, Kathryn Lallinger, Adam Kroetsch, Huzyfa Fazili, Marta Wosińska, Mark McClellan
2020
Read MoreBlog Entry
Real-World Evidence to Increase Value in Health Care
Mark McClellan, Gregory Daniels, Andrea Thoumi, and Morgan Romine
Mark McClellan, Gregory Daniels, Andrea Thoumi, and Morgan Romine
2018
Read MoreWhite Paper
Characterizing RWD Quality and Relevancy for Regulatory Purposes
Gregory Daniel, Christina Silcox, Jonathan Bryan, Mark McClellan, Morgan Romine, Katherine Frank
Gregory Daniel, Christina Silcox, Jonathan Bryan, Mark McClellan, Morgan Romine, Katherine Frank
2018
Read MoreBlog Entry
Real-World Evidence to Increase Value in Health Care
Mark McClellan, Gregory Daniel, Andrea Thoumi, Morgan Romine
Mark McClellan, Gregory Daniel, Andrea Thoumi, Morgan Romine
2018
Read MoreNews About Real-World Evidence
More NewsNews 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 improve the evaluation of the effectiveness of drugs in the marketplace, according to the Duke-Margolis Center for Health Policy. In a new white paper, Duke-Margolis discusses how submissions reviewed...
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 framework to characterize the reliability of real-world data (RWD) to support fitness for use in drug development and regulation. RWD is information about patient health status and health care delivery...
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 widespread adoption of electronic health records and the popularity of digital health tools, such as wearable devices, biosensors, apps, and remote patient monitoring. A new report released by the...
Washington, D.C. — Today, the amount of electronic health care data is rapidly growing due to the...
Read MoreNews Update January 16, 2018
Mark McClellan Comments on Azar Nomination
Read more in Modern Healthcare.
Read more in Modern Healthcare.
Read MoreTopics Related to Real-World Evidence
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Trending Topic
Biomedical Innovation
Duke-Margolis, in partnership with FDA and a wide array of other stakeholder groups, is focused on…