Re: Apabetalone......a Calculated Risk
in response to
by
posted on
Apr 09, 2019 08:34AM
Tada wrote "If the odds of success were about 53% when BoM started and all of the data is blinded how can the odds of success increase?"
Perhaps the 9 positive DSMB reports can increase the odds of success, as Paladin suggested. Also, if a trial passes pre-specified interim analyses, such as futility analysis or sample size re-estimation analysis, then this may be interpreted as a positive and possibly increase the odds of success. However, Resverlogix opted to not perform the pre-specified futility analysis at 50% of events or the sample size re-estimation analysis at 75% of events.
Paladin wrote "I suspect there would be somewhat of a increase from the initial 53% due to the diminished concerns over safety resulting from the 9 positive DSMB reports.....if APL was totally ineffective then would they not have stopped the trial at some point (???) although I’m not sure how that works if the trial is blinded."
I agree that the 9 positive DSMB reports are a plus and suggest, in my opinion, at the very least that: 1) apabetalone is not eliciting any unanticipated adverse events construed to be drug related; and 2) apabetalone is not increasing the risk for MACE. Since the interim futility and sample size re-estimation analyses were not performed, there is still a chance, in my opinion, that BETonMACE continues while apabetalone has no appreciable benefit. However, that is not my favored view based upon all of the clinical and pre-clinical evidence. By the way, the DSMB is not blinded.
BearDownAZ