Great post! By definition the DMSB is charge with
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Posted On: 12/26/2020 11:12:27 PM
Re: ClosetInvestor #69787
Great post! By definition the DMSB is charge with two tasks: mission safety and efficacy, if a p values trigger a reason to stop the trial they have the singular power to do so. Obviously the safety issues did not reach the threshold.
In terms of efficacy it did not meet the criteria of p< .005 and factoring type one error, so I believe they recommending completion of the trial. They probably took in consideration of type one errors and strict statistical analysis, and the change of SOC which includes DEX and now Methlpredisone.
in addition the trial was not completed and subject to rigorous statistical analysis. I short the safety was established but not efficacy, that is up to the sponsor. My caveat: this data from unblinded report is very sensitive issue : even body language of anyone invited to their meetings is suspect when talking to the sponsor.
In terms of efficacy it did not meet the criteria of p< .005 and factoring type one error, so I believe they recommending completion of the trial. They probably took in consideration of type one errors and strict statistical analysis, and the change of SOC which includes DEX and now Methlpredisone.
in addition the trial was not completed and subject to rigorous statistical analysis. I short the safety was established but not efficacy, that is up to the sponsor. My caveat: this data from unblinded report is very sensitive issue : even body language of anyone invited to their meetings is suspect when talking to the sponsor.
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