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Posted On: 09/10/2021 6:49:56 PM
Post# of 148902
Regarding interim analysis, what do you guys think the lessons learned are and will CYDY do things differently?
1) take the p-value hit and unblind at 40%? Don't rely too much on the DSMC's word. See the data for themselves.
2) halt the enrollment at 40% to see if the data indicates any protocol tweaks required to meet endpoints for the remaining 60%?
3) don't halt enrollment and full speed ahead while in parallel analyzing data at 40% and stop only for overwhelming efficacy?
1) take the p-value hit and unblind at 40%? Don't rely too much on the DSMC's word. See the data for themselves.
2) halt the enrollment at 40% to see if the data indicates any protocol tweaks required to meet endpoints for the remaining 60%?
3) don't halt enrollment and full speed ahead while in parallel analyzing data at 40% and stop only for overwhelming efficacy?
(2)
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