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Posted On: 03/08/2021 9:11:14 AM
Post# of 148936
I woke up this morning thinking about the DSMB asking for a read out at 75% with 42 day mortality. We all kind of assumed this was an attempt to get to statistical significance with an incomplete enrollment. However, I'm thinking the DSMB saw there was an imbalance in the trial and the 42 day readout was an attempt to see if the placebo arm more closely mirrored the actual mortality seen at hospitals and other trials. The significance of this is that at the 50% readout, action could have been taken if the DSMB had more clearly explained why the wanted another readout. It could be management decided to just keep going as designed in hopes the patient population problem would right itself, which puts us a great risk of this very situation. I am assuming that the data release has already had a 42 day assessment and it did not help things, it would seem that the placebo arm was abnormally too healthy period. this is the curse of the small blinded trial, we don't know until it is too late to fix it.
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