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Hyatt Regency Cambridge

Nov 14, 2019 7:30 AM - Nov 15, 2019 12:30 PM

575 Memorial Drive, Cambridge, MA 02139

Real World Evidence Conference

How Real World Evidence can be used for regulatory purposes

Session 2: Sizing Up Data Bases and Their Sufficient Fit for Purpose

Session Chair(s)

Nancy A Dreyer, PhD, MPH, FISPE

Nancy A Dreyer, PhD, MPH, FISPE


Dreyer Strategies LLC, United States

Brian  Bradbury, DrSc, MA

Brian Bradbury, DrSc, MA

Vice President, Center for Observational Research

Amgen, United States

The spectrum of data sources for RWE runs the spectrum from pure reliance on existing data to prospective non-interventional studies, randomized trials, and various combinations of linked data. Evaluating quality for a given purpose starts with understanding how the data is collected, where it comes from, and how must-have exposures and outcomes are recorded. Real-world examples showing how diverse types of real-world data outcomes are being validated and used will be presented.

Learning Objective :
  • Describe the spectrum of evidence that is considered real-world and what circumstances would generally exclude data from being reflective of the “real-world”
  • Describe key elements of real-world data that should be considered when existing data, primary data collection, and data linkage
  • Discuss at least one example of modern-day use of real-world evidence including why exposure and outcomes were useful as well as any concerns about limitations


Michael  Fried, MD


Michael Fried, MD

Target RWE, United States

Co-Founder & Chief Medical Officer

Todd  Johnson, MD, MBA

Making Fit-for-Purpose EHR Data Scalable Via a Digital Research Network

Todd Johnson, MD, MBA

Optum, United States

Senior Vice President, Clinical Research and Head, Digital Research Network

David  Martin, MD, MPH

Primary Data Collection through the FDA MyStudies Mobile App

David Martin, MD, MPH

Moderna, United States

Vice President, Global Head RWE

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