I was speaking with a PharmD and hopefully you can
Post# of 154678
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Posted On: 09/29/2020 6:53:27 PM
Re: Borel Fields #58471
I was speaking with a PharmD and hopefully you can confirm the logic behind the significance of the penalty in p-value.
From what he was saying, typically the Halt for Efficacy at Interim Analysis for 50% enrollment will be equal to that of the penalty for unblinding, if required to go to completion.
Ex:
Halt at Interim= p<0.005
Penalty for Unblinding= p=0.005
Completion of Trial (post penalty): p<0.045
*Assuming the p value boundary is consistent with this, and we need p<0.005 to get halted, what kind of mortality numbers are we needing LL/control (130/65)
From what he was saying, typically the Halt for Efficacy at Interim Analysis for 50% enrollment will be equal to that of the penalty for unblinding, if required to go to completion.
Ex:
Halt at Interim= p<0.005
Penalty for Unblinding= p=0.005
Completion of Trial (post penalty): p<0.045
*Assuming the p value boundary is consistent with this, and we need p<0.005 to get halted, what kind of mortality numbers are we needing LL/control (130/65)
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