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Re: misiu143 post# 163247

Monday, 05/03/2021 4:16:32 PM

Monday, May 03, 2021 4:16:32 PM

Post# of 233221

Everyone knows the less patients the more difficult to meet anything.


If the drug is actually efficacious, it is more difficult to have stat sig in a small trial. If the drug is a dud, it is far easier to show stat sig in a small trial. A trial of 83 patients or a subgroup of 62 patients can have wild variation because of randomness.

SAEs are not an endpoint. And they aren't necessarily related to the drug or placebo. If you get injured in a car accident, that counts as a SAE. If you break your toe playing football, that counts as an SAE. No conclusions can be drawn from SAE data. Since the trial failed, it can be concluded that the SAE data was random.
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