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Posted On: 02/26/2021 6:47:40 AM
Post# of 153899
mtruong,
Please remember that we are making assumptions on necessarily incomplete information.
Please remember that we are making assumptions on necessarily incomplete information.
Quote:
In CYDY's haste to complete the trial, there was a missed opportunity in bypassing the DSMC's recommendation./quote]
It is quite plausible that the 75% interim analysis, and 42 mortality evaluation, was a mechanism to halt trial early if 50% mortality was very close to sufficient to demonstrating of overwhelming efficacy.
The interim analysis, with lower power, apparently would have occurred just a couple of weeks prior to full trial completion due to rapid enrollment at the end of the trial.
Again, the trial was not modified, just the interim analysis.
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.
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