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Observational Studies of Comparative Effectiveness: How to Recognize Good Practice

Track:
Comparative Effectiveness Research/Global Health Outcomes and Economics

Day & Time:
June 16, 11:00AM - 12:30PM (Pacific Standard Time)

Session Number:
138

Room Number:
9

Level:
Basic

Type:
Forum

Title:
Observational Studies of Comparative Effectiveness: How to Recognize Good Practice

Chair(s):
Nancy A. Dreyer, PhD, MPH, FISPE
Global Chief of Scientific Affairs, Real-World and Late Phase Research
Quintiles Realworld & Late Phase Research, United States

Description:
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(s):
Differentiate the purposes that real-world data serve for industry, government, and payers; Appraise real-world studies in terms of their fit for purpose.

Presentation(s) & Speaker(s):
Best Evidence to Support Regulatory Decision Making
Jordi Llinares Garcia, MD, PhD
Head of Product Development Scientific Support Department
European Medicines Agency, European Union, United Kingdom

The Practice of Observational Research in Risk Management
J. Michael Sprafka, PhD, MPH
Executive Director, General Medicine, Inflammation & Bone TA Lead
Amgen Inc., United States

Using the GRACE Checklist for Quality in Observational Research
Nancy A. Dreyer, PhD, MPH, FISPE
Global Chief of Scientific Affairs, Real-World and Late Phase Research
Quintiles Realworld & Late Phase Research, United States