Real-World Evidence

Projects Relating to Real-World Evidence

Project

COVID-19 Evidence Accelerator

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Project

Building Capacity for Patient Engagement in Real-World Evidence Development

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Project

Real-World Evidence Collaborative

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Duke-Margolis Faculty & Research Team

adam aten

Adam Aten, MPH, MSc

Research Associate

Laura Benzing

Laura Benzing

2020 Margolis Intern

Eckert

Joy Eckert, MPH

Research Associate

Kroetsch

Adam Kroetsch, MPP

Research Director, Biomedical Innovation and Regulatory Policy
 Senior Team Member

Lederer

Nirosha Mahendraratnam Lederer, PhD, MSPH

Managing Associate, Real World Evidence
 Senior Team Member
 2020 Intern Mentor

Mark McClellan

Mark McClellan, MD, PhD

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

Mercon

Kerra Mercon

Senior Research Assistant

Photo of Valerie Parker

Valerie Parker

Policy Analyst

morgan romine

Morgan Romine, MPA

Chief of Staff
 Senior Team Member

silcox

Christina Silcox, PhD

Digital Health Policy Fellow
 Adjunct Assistant Professor
 Senior Team Member
 Margolis Core Faculty

Photo of Kelly Wahl

Kelly Wahl, MPH

Research Associate

Events About Real-World Evidence

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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)…

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Event 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…

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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…

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Event 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…

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Publications About Real-World Evidence

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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

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Blog Entry

Real-World Evidence to Increase Value in Health Care

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

2018

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White Paper

Characterizing RWD Quality and Relevancy for Regulatory Purposes

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

2018

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Blog Entry

Real-World Evidence to Increase Value in Health Care

Mark McClellan, Gregory Daniel, Andrea Thoumi, Morgan Romine

2018

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News About Real-World Evidence

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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...

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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...

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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...

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News Update January 16, 2018

Mark McClellan Comments on Azar Nomination

Read more in Modern Healthcare.

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Topics Related to Real-World Evidence

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biomedical innovation

Trending Topic

Biomedical Innovation

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