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InterContinental San Francisco

Nov 05, 2018 7:00 AM - Nov 06, 2018 3:00 PM

888 Howard Street, San Francisco, CA 94103

Real World Evidence Conference

This conference has reached maximum capacity.

Session 8: When RWD Are Good Enough to be Reliable: Recognizing Fit-for-Purpose Evidence

Session Chair(s)

Nancy A Dreyer, PhD, MPH, FISPE

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)

Nancy A Dreyer, PhD, MPH, FISPE

When Real-World Data Are Reliable: Recognizing quality in a fit-for-purpose context : Nancy A Dreyer, PhD, MPH, FISPE

Founder

Dreyer Strategies LLC, United States

Peter P. Stein, MD

When RWD Are Good Enough to be Reliable: Recognizing Fit-for-Purpose Evidence : Peter P. Stein, MD

Director, Office of New Drugs, CDER

FDA, United States

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