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Session 8: When RWD Are Good Enough to be Reliable: Recognizing Fit-for-Purpose Evidence
Session Chair(s)
Nancy A Dreyer, PhD, MPH, FISPE
Founder
Dreyer Strategies LLC, United States
The session is aimed to provide an overview of how to determine whether real-world data are adequate to get a reasonably robust answer for the study objective. A summary of the current landscape including innovations happening now in regulatory settings will be presented. Key aspects of evaluating RWE quality will be provided and contrasted with metrics used for RCT. References will be provided with links to influential guidance documents in the US and EU.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe how non-randomized studies are being used for label expansions and cite > 1 example
- Name >1 features that describes good quality for RWE and how that differs from related good practice for RCT
- Explain why it is important to understand the health systems or other type of RWE (e.g., electronic medical records) and be able to describe the reference population
Speaker(s)
When Real-World Data Are Reliable: Recognizing quality in a fit-for-purpose context
Nancy A Dreyer, PhD, MPH, FISPE
Dreyer Strategies LLC, United States
Founder
When RWD Are Good Enough to be Reliable: Recognizing Fit-for-Purpose Evidence
Peter P. Stein, MD
FDA, United States
Director, Office of New Drugs, CDER