RWE and the FDA (Part 2)
The Effective Statistician - in association with PSI
00:00
Are There Factors That Drive Misclassification?
A real world data will perhaps lend itself better to the sort of harder types of outcomes. And very often you have larger sample sizes. So that makes it possible then also to still see something. FDA expects validation of the outcome variable to minimize outcome misclassification.
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