Key Takeaways
- Real-world evidence still is rarely central to FDA approval decisions, but the agency noted real-world data’s contribution to a new indication for Genentech’s Actemra (tocilizumab) and a new pediatric dosing regimen for UCB’s Vimpat.
- The FDA Sentinel RWE Data Enterprise’s linked electronic health records and claims data are helping identify outcomes and variables in structured and unstructured data for postmarketing safety surveillance.
- RWE can improve postmarketing pregnancy safety studies, potentially helping with traditionally slow enrollment, as well as signal detection.
Real-world evidence is firmly entrenched in the regulatory and drug development toolbox, but grand visions of approvals with RWE in a starring role are dimming in favor of emerging supporting...
In drug development, RWE and real-world data should not be seen as an alternative to traditional randomized controlled trials, but as tools to improve studies, John Concato, outgoing associate director...
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