Real-World Evidence

Project

COVID-19 Evidence Accelerator

Project

Building Capacity for Patient Engagement in Real-World Evidence Development

Project

Real-World Evidence Collaborative

Nancy Allen LaPointe

Faculty Fellow, Duke-Margolis Center for Health Policy
Adjunct Associate Professor in the Department of Medicine Faculty

Adam Aten, MPH, MSc

Research Associate

Laura Benzing

2020 Margolis Intern

Hayden Bosworth, PhD

Professor in Population Health Sciences
Margolis Affiliated Faculty

Tong Guo, PhD

Assistant Professor in Marketing
Appointment in Department of Economics

Rachele Hendricks-Sturrup, DHSc, MSc, MA

Research Director
Senior Team Member

Trevan Locke, PhD

Research Associate

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

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

Event 3/12/2021

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…

Event 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)…

Event 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…

Event 7/13-7/14/2020

Establishing a High-Quality Real-World Data Ecosystem Day 1 & 2

The Duke-Margolis Center for Health Policy, in partnership with the U.S. Food and Drug…

White 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

2020

Blog Entry

Real-World Evidence to Increase Value in Health Care

Mark McClellan, Gregory Daniels, Andrea Thoumi, and Morgan Romine

2018

White Paper

Characterizing RWD Quality and Relevancy for Regulatory Purposes

Gregory Daniel, Christina Silcox, Jonathan Bryan, Mark McClellan, Morgan Romine, Katherine Frank

2018

Blog Entry

Real-World Evidence to Increase Value in Health Care

Mark McClellan, Gregory Daniel, Andrea Thoumi, Morgan Romine

2018

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...

Press 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...

News 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...

News Update January 16, 2018

Mark McClellan Comments on Azar Nomination

Biomedical Innovation

Duke-Margolis, in partnership with FDA and a wide array of other stakeholder groups, is focused on…

Real-World Evidence

Projects Relating to Real-World Evidence

COVID-19 Evidence Accelerator

Building Capacity for Patient Engagement in Real-World Evidence Development

Real-World Evidence Collaborative

Duke-Margolis Faculty & Research Team

Nancy Allen LaPointe

Adam Aten, MPH, MSc

Laura Benzing

Hayden Bosworth, PhD

Tong Guo, PhD

Rachele Hendricks-Sturrup, DHSc, MSc, MA

Trevan Locke, PhD

Herbert Kim Lyerly, MD

Mark McClellan, MD, PhD

Valerie Parker

Morgan Romine, MPA

Christina Silcox, PhD

Events About Real-World Evidence

An Introduction to Real-World Data & Real-World Evidence: A Virtual Training Series for the Patient Community

Evaluating RWE from Observational Studies in Regulatory Decision-Making: Lessons Learned from Trial Replication Analyses

Developing Study Endpoints in Real-World Settings

Establishing a High-Quality Real-World Data Ecosystem Day 1 & 2

Publications About Real-World Evidence

A Roadmap for Developing Study Endpoints in Real-World Settings

Real-World Evidence to Increase Value in Health Care

Characterizing RWD Quality and Relevancy for Regulatory Purposes

Real-World Evidence to Increase Value in Health Care

News About Real-World Evidence

New Evidence Approach Recommended to Evaluate Medical Product Effectiveness

Press Release: Evaluating Real-World Data Reliability for Drug Development and Regulation

New BPC Report Calls for Expanded Use of Real-World Evidence for Decision-Making on Drugs and Biologics

Mark McClellan Comments on Azar Nomination

Topics Related to Real-World Evidence

Biomedical Innovation