Tuesday, February 12, 2019 3:49:00 AM
I don't know what is blinded but I can rely on trial registration document and it says clearly that it is un-blinded, and the reason you mention are absolutely valid (it couldn't have been blinded) which means that M. Smith who is taking the drug is recorded in the DB as having taking the drug and M. Vangala will be recorded as member of the SOC group. Patient is un-blinded and doctor is un-blinded.
So the data itself is recorded with this information. Whether it is for the CRO eyes only or encrypted until 298th event, you have to rely on management word, not on facts. What you don't know is if they really don't know or if they just can't reveal the figure. It's easier for them to say "we don't know" than to say "We know but cannot disclose because of the risk jeopardising the whole study" (it ain't over till it's over).
It's exactly the same for the number of events. Nobody thought about asking them ? If so, what was the answer ? We know for a fact that they are monitoring this figure. We know they know. They know also that we know that they know. That's why may-be they removed the planned end-date from early 2019
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