We all know the DSMC wasn't looking at efficacy.
Post# of 155044
(Total Views: 627)
Posted On: 08/16/2020 9:59:10 AM
Re: KCRoyal2004 #49881
We all know the DSMC wasn't looking at efficacy. As you pointed out, we were told it was a safety look beforehand, and efficacy could never have been analyzed in one day.
It was very clear that the company was asking for a safety look to serve as a proxy for efficacy -- meaning, if the subjects in both the treatment and placebo arms were looked at for safety, and an inordinate number of placebo arm subjects had died, the trial could conceivably be terminated for overwhelming benefit.
The two points of contention are:
1. How does one reconcile the number of treatment arm subjects that were reportedly reviewed by the DSMC -- with the estimate of how many of them could have completed the PE of Day 28 Mortality, or the SE of Day 14 Mortality? And were the placebo arm subjects even looked at for safety? However, this is an academic question that is no longer worth solving for "x".
2. How did a DSMC review of safety that was described multiple times by management as being conducted for the sole purpose of possibly terminating the trial -- morph into an effort to generally confirm the safety of leronlimab? We all know the safety of leronlimab, and confirming its safety as a therapy was not the stated purpose of the DSMC review. But again, for reasons that I hypothesized at the end of my post, there were likely compelling reasons why the DSMC did not recommend termination.
However, this is all history, and actually quite meaningless at this point. It was just an exercise attempting to reconcile the numbers and the purpose of the DSMC review.
It was very clear that the company was asking for a safety look to serve as a proxy for efficacy -- meaning, if the subjects in both the treatment and placebo arms were looked at for safety, and an inordinate number of placebo arm subjects had died, the trial could conceivably be terminated for overwhelming benefit.
The two points of contention are:
1. How does one reconcile the number of treatment arm subjects that were reportedly reviewed by the DSMC -- with the estimate of how many of them could have completed the PE of Day 28 Mortality, or the SE of Day 14 Mortality? And were the placebo arm subjects even looked at for safety? However, this is an academic question that is no longer worth solving for "x".
2. How did a DSMC review of safety that was described multiple times by management as being conducted for the sole purpose of possibly terminating the trial -- morph into an effort to generally confirm the safety of leronlimab? We all know the safety of leronlimab, and confirming its safety as a therapy was not the stated purpose of the DSMC review. But again, for reasons that I hypothesized at the end of my post, there were likely compelling reasons why the DSMC did not recommend termination.
However, this is all history, and actually quite meaningless at this point. It was just an exercise attempting to reconcile the numbers and the purpose of the DSMC review.
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