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Message: Re: Apabetalone......a Calculated Risk

"Bear is DSMB sworn to secrecy seeing that they are not blinded?"

I may have overstepped by saying that the DSMB is unblinded. While the participants, investigators, doctors or sponsors are unaware of whether a patient is getting placebo or apabetalone, the DSMB may have access to "masked" data that allows them to know which patients are in group "X" vs. group "Y". However, the DSMB may not know whether "X" or "Y" is placebo or apabetalone. I think in certain circumstances it becomes necessary for the DSMB to become unblinded; however, in most cases they may just know "X" vs. "Y" without knowing placebo vs. apabetalone. Here's a good summary on the role of the DSMB.

Your question about whether the DSMB is sworn to secrecy seems to be questioning the integrity of the entire clinical trial process for all past, current and future blinded clinical trials. BETonMACE is just like any other blinded cardiovascular outcomes trial that has a DSMB. No need for conspiracy theories.

BearDownAZ

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