RWE and the FDA (Part 1)
The Effective Statistician - in association with PSI
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The FDA Definition of Real World Data
The fda has a definition of real world data, but theyn mention in their real world evidence framework document and their recently released draft guidances. Data relating to patient ha status is actually a pretty broad thing, isn't it? So how would that cand of if you would have, for example, patient reported outcoes? Is it part of rewar data potentially, isn’t it? I guess potentially, yes, yes, it is.
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