But some of the FDA initiatives that Gottlieb wanted involved using fewer patients in the clinical trials, and using (anonymous) electronic medical records to form the control group -- so that in something like Bril-OM, everyone in the study could get the drug. When you have a large population that DOESN'T get it, they can constitute a great control group (even if it isn't a double-blinded study).
I read recently about some drug that was approved with just 32 participants in the drug arm of the study. Sorry, can't remember which drug that was.
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