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Observational Studies of Comparative Effectiveness: How to Recognize Good Practice
Session Chair(s)
Nancy A Dreyer, PhD, 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)
Best Evidence to Support Regulatory Decision Making
Jordi Llinares Garcia, MS
European Medicines Agency, Netherlands
Head of Research and Innovation
The Practice of Observational Research in Risk Management
J. Michael Sprafka, PhD, MPH
Amgen Inc., United States
Executive Director, General Medicine, Inflammation & Bone TA Lead
Using the GRACE Checklist for Quality in Observational Research
Nancy A Dreyer, PhD, MPH, FISPE
Dreyer Strategies LLC, United States
Founder
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