It all depends on how the DSMC charter was written
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Posted On: 12/15/2021 3:27:51 PM
It all depends on how the DSMC charter was written, but in general, no, I don't think they were tasked to examine, comment on, or recommend changes to deal with randomization discrepancies with the over 65 more heavily weighted to one group. Likewise I don't think it's their job to recommend dosing changes. That is all on the study sponsors to figure out for the next trial if subjects were overdosed or underdosed.
It seems pretty clear that our critical subjects were underdosed, but we'll have to see if the Brazil trial proves that out. Science certainly suggests it too. I do blame FDA for that, but not the DSMC.
DSMC in general isn't tasked to try to make a trial show a positive outcome. They are just supposed to look mainly at safety, and when (t)asked, to also peak at efficacy numbers and decide if outlook is really bleak or really bright, then to recommend changes. Our interim efficacy analysis apparently wasn't at either extreme, so it continued on as planned. The only curious thing was why they asked to extend the mortality endpoint out past 28 days to 42 days.
Look, I'm not privy to all the details of our DSMC interim look for CD12 or any of the details of their charter and their other meetings. I just wanted to say we have no evidence to suggest any deliberate sabotage, certainly not by the FDA with respect to the DSMC. But anything is possible.
The GILD remdesivir thing was also suspect. But it is claimed that the NIAID statisticians made their recommendation to change the endpoint before they looked at any data. Who knows what really happened, but it makes sense on the face of things. People are going to make their own conclusions regardless. Some opinions will be well supported, and others not.
It seems pretty clear that our critical subjects were underdosed, but we'll have to see if the Brazil trial proves that out. Science certainly suggests it too. I do blame FDA for that, but not the DSMC.
DSMC in general isn't tasked to try to make a trial show a positive outcome. They are just supposed to look mainly at safety, and when (t)asked, to also peak at efficacy numbers and decide if outlook is really bleak or really bright, then to recommend changes. Our interim efficacy analysis apparently wasn't at either extreme, so it continued on as planned. The only curious thing was why they asked to extend the mortality endpoint out past 28 days to 42 days.
Look, I'm not privy to all the details of our DSMC interim look for CD12 or any of the details of their charter and their other meetings. I just wanted to say we have no evidence to suggest any deliberate sabotage, certainly not by the FDA with respect to the DSMC. But anything is possible.
The GILD remdesivir thing was also suspect. But it is claimed that the NIAID statisticians made their recommendation to change the endpoint before they looked at any data. Who knows what really happened, but it makes sense on the face of things. People are going to make their own conclusions regardless. Some opinions will be well supported, and others not.
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