“DSMC recommendation to continue without changin
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Posted On: 10/20/2020 10:38:19 PM
Re: crazyjogger925 #62459
“DSMC recommendation to continue without changing Endpoints or Number of Subjects IS HUGE..!!!”
In this case, I agree with NP on the decision to NOT unblind the data and take the penalty. Yes, the DSMC recommended to continue the trial but we don’t know exactly why and what the p value was. We can assume that if the efficacy was clear and the P value was significant, that the trial would’ve likely been halted. So it’s likely the p value was trending in the right direction but was not quite significant. So, unblinding by CYDY would not be in the best interest of the trial in the long run.
In this case, I agree with NP on the decision to NOT unblind the data and take the penalty. Yes, the DSMC recommended to continue the trial but we don’t know exactly why and what the p value was. We can assume that if the efficacy was clear and the P value was significant, that the trial would’ve likely been halted. So it’s likely the p value was trending in the right direction but was not quite significant. So, unblinding by CYDY would not be in the best interest of the trial in the long run.
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