(Total Views: 430)
Posted On: 02/26/2021 7:01:46 AM
Post# of 155792
CT Medic wrote:
It's my understanding that a DSMB recommendation is just that, a recommendation -- if the committee isn't stopping the trial, then it's up to the sponsor to decide whether to take that recommendation. Correct me if I'm wrong about this.
NP surely decided that, given the lower bar of full-enrollment results, we didn't need to increase our chances with the longer timeframe, and those extra 14 days would just mean it would take 14 days longer before getting results. Which, of course, none of us here wanted.
Quote:
The DSMB, seeing the unblinded data, allowed unmodified continuation to completion. This means that the trial, as designed, was expected to demonstrate efficacy with statistical significance in the primary endpoint at full enrollment.
It's my understanding that a DSMB recommendation is just that, a recommendation -- if the committee isn't stopping the trial, then it's up to the sponsor to decide whether to take that recommendation. Correct me if I'm wrong about this.
NP surely decided that, given the lower bar of full-enrollment results, we didn't need to increase our chances with the longer timeframe, and those extra 14 days would just mean it would take 14 days longer before getting results. Which, of course, none of us here wanted.
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