Real-World Evidence: Observational Studies Deserve More Respect In US FDA Framework

 
• By Sue Sutter

Biopharma industry urges agency to open the door wider to use of non-randomized observational studies to support efficacy claims, but insurer Kaiser Permanente calls such studies problematic.

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Industry wants an open door for use of observational studies to support efficacy claims. • Source: Shutterstock

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