And hence my gripe They have given several soft indications of something is coming. I am not saying it’s their fault . But they just need to tell us what happened and what is going on . For sake of transparency why can’t they answer two simple questions : - was IA done or not ( yes or no question - not asking what the results were ) - what was the reason for the halt
How would answering any of this at this stage impact trial integrity as all the patients have received all the treatments and no more patients are being randomized . But I am sure someone will come up with some justification for it to decent the management ....!!
hopeforthefuture, about David Innes' description of beta lock you are right. I misinterpreted DI's description of the soft data lock. Looking back he said that there is an interval during which no results will be added. I misinterpreted that he meant hard lock but that can't be because after hard lock we need no time interval. Unblinding can proceed immediately.
I think now I understand what is happening. It is now almost June and the soft data lock has not yet been installed. Any event can still be accepted in the data base and we are almost in July and almost 47 months past the last surgery. That is a long time and maybe we will have a few more months before the new events will not be entered. I am betting that the attrition rate is so low now, that the pending soft data lock will not be very important and will not exclude crucial data.
The trouble is that for me to decipher the content of DI's message is like unlocking the Rosetta Stone. I know that DI is not allowed to give us material information so he has to keep his answers vague and ambiguous. That is not his fault.
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