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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

  • Chief Scientific Officer and Senior Vice President
  • IQVIA, United States
Brian D. Bradbury, PhD, MA

Brian D. Bradbury, PhD, 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

  • Co-Founder & Chief Medical Officer
  • TARGET PharmaSolutions, United States
Todd  Johnson, MD, MBA

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

Todd Johnson, MD, MBA

  • Senior Vice President, Clinical Research and Head, Digital Research Network
  • Optum, United States
David  Martin, MD, MPH

Primary Data Collection through the FDA MyStudies Mobile App

David Martin, MD, MPH

  • Vice President, Pharmacovigilance
  • Moderna, United States

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