RWE and the FDA (Part 1)
The Effective Statistician - in association with PSI
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Are You Using Clinical Trials?
Exposure is a very, very different beast if you look into real data. You need to know that the exposure you're interested in studying can be reliably ascertained from your your data source. In this guidance document fda, they really put a lot of emphasis on defining your concept definition and case definition.
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