Re: Clarification received...
in response to
by
posted on
Jun 09, 2018 11:11PM
Bear
you said “ It is the CSC that makes important decisions regarding the trial. However, if the CSC chooses to do the SSRA, it would instruct the independent DSMB to perform this interim analysis.”
You stated this as fact and not your opinion, even though Sarah had replied to both Kelsee and GAC that it would be the CSC that “does” an SSRA. A company spokeswoman stated this. I get your logic that it would be likely that the DSMB would conduct the SSRA as you laid out (as well as other additional logic as to how the CSC could conduct a proper SSRA when the CSC is supposed to be blinded and therefor it could be logical to assume that the unblinded DSMB would be the ones doing the SSRA.)
But I repeat .. you stated in a manner of fact that the DSMB would perform “this interim analysis” (referring to the SSRA)
Would it not be best to avoid making such statements until you received proper clarification from the company?
respectfully
DND