posted on
Aug 28, 2017 04:46PM

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Message: DSMB
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I'm no DSMB expert, but my opinion is that at each of the four DSMB checks that have occurred so far that the DSMB had all unblinded data available when making their assessments. I think it is doubtful that they get notified as each MACE event happens but instead reviews available data at each safety check. Each MACE event has to be adjudicated, but I'm pretty sure that this is done by a group independent of the DSMB. I'm not entirely sure what triggered each DSMB safety check, but most likely after a certain amount of time elapsed since study began. Does the DSMB have an idea of whether apabetalone is having efficacy to affect incidence of 3-point MACE? Of course they would.... they have access to the unblinded data! But with the study not even being halfway done (not to 125 events yet) it is very unlikely that any trends that are forming are statistically strong enough to allow the groups to be found significantly different from one another. In any case, I don't think the DSMB recommends any action (continue or halt) based on MACE trends until the 125 event futility analysis. All just my opinion!
BearDownAZ
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