Real-World Evidence: Efficacy Assessments Await FDA Clarity, Pilot Projects
Greater development and use of real-world evidence, such as pragmatic clinical trials and observational studies, to support regulatory decisions on drug efficacy are limited by regulatory, technical and practical hurdles, stakeholders say.
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US FDA Is Hesitant About Using Observational Studies In Real-World Evidence Framework
Agency plans guidance on whether observational studies can provide real-world evidence to support regulatory decisions about drug effectiveness; however, RWE framework includes critical questions about retrospective studies, and reflects agency concerns about transparency.
Duke's McClellan: Changing Drug Development Policy From Outside FDA
In an interview, Margolis Center for Health Policy's Mark McClellan and Gregory Daniel talk about their recent move from Brookings to Duke, the breadth and impact of their work with FDA on drug development issues, and opportunities for potential future collaborations under PDUFA VI.
PDUFA VI: Breakthrough Issues Among FDA Priorities
Agency and industry also decide to drop research into using social media to enhance post-market safety monitoring.