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Session 2: Sizing Up Data Bases and Their Sufficient Fit for Purpose
Session Chair(s)
Nancy Dreyer, PhD, MPH, FISPE
Founder
Dreyer Strategies LLC, United States
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
Speaker(s)
Speaker
Michael Fried, MD
Target RWE, United States
Co-Founder & Chief Medical Officer
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
Primary Data Collection through the FDA MyStudies Mobile App
David Martin, MD, MPH
Novartis, United States
Vice President, Head, PCO Center of Excellence
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