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Request to Reconsider Assessment Wawa  Form

Request to Reconsider Assessment Wawa Form

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[Music] hi everyone this is Don with Derek that's me it's April and we're going to talk about real world evidence studies I think you all know that rwe studies are becoming more and more common in FDA submissions and I think that's a great thing because they in my opinion better reflect the reality of of you know a patient's life and how an inter mention um impacts that but what I also see is that rwe and post Marketing in phase four is often um kind of the orphan in the mix of studies and a lot of money and time is spent on big expensive rcts but when it comes to the later phas studies or the rwe projects we uh we try to save money uh we do uh try to keep it simple and um simple is good by the way but not too simple uh and sometimes we compromise on methodology and I saw a study recently that showed that there were quite a few FDA submissions that included real world evidence uh but that the FDA also threw out some of those rbe studies because t

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