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Re: ombowstring post# 123265

Wednesday, 10/14/2020 9:49:18 AM

Wednesday, October 14, 2020 9:49:18 AM

Post# of 233053
From what I heard you are likely to pay .0005 penalty in P factor at trial completion if you elect to unblind at interim when told to continue. So for arguments sake let’s just say now your final results would have to be a P factor of .0045 vs. .005. Due to improved SOC since the beginning of the pandemic, that p factor for efficacy could be even lower in a trial based on deaths. - say .0035 vs. .004

The reason for the penalty is that if the trial is unblinded at interim when told to continue, then there is a chance that the sponsor - CytoDyn - could sway the CRO who is doing the analysis - Amerex - into adjusting its analysis to improve final data at trial completion. In effect, the penalty is paid due to the likelihood of trial analysis contamination or skew.
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