RWE and the FDA (Part 2)
The Effective Statistician - in association with PSI
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The Golden Rule of Study Failability
You need to do some kind of study feasibility. How are you going to know that you have enough patients to meet your study objectives if you haven't at least queried the data sufficiently? The golden rule is don't look at outcomes by exposure group and during the feasibility. And I think that's also another key way of making your results reliable, shall we say. So any final points in terms of FDA and real world evidence, his thoughts on that?
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