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Observational Studies of Comparative Effectiveness: How to Recognize Good Practice
Session Chair(s)
Nancy Dreyer, MPH, FISPE
Founder, Dreyer Strategies LLC, United States
Understanding that a randomized clinical trial can only be used to answer a tiny fraction of questions, this forum addresses how real-world data are used from the perspective of industry, government, and payers, and how quality observational research can be identified.
Learning Objective : Differentiate the purposes that real-world data serve for industry, government, and payers; Appraise real-world studies in terms of their fit for purpose.
Speaker(s)
Jordi Llinares Garcia, MS
Head of Research and Innovation, European Medicines Agency, Netherlands
Best Evidence to Support Regulatory Decision Making
J. Michael Sprafka, PHD, MPH
Executive Director, General Medicine, Inflammation & Bone TA Lead, Amgen Inc., United States
The Practice of Observational Research in Risk Management
Nancy Dreyer, MPH, FISPE
Founder, Dreyer Strategies LLC, United States
Using the GRACE Checklist for Quality in Observational Research
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