In Phase 2 trials, the primary end point is not va
Post# of 154118
(Total Views: 646)
Posted On: 08/06/2020 2:41:38 PM
In Phase 2 trials, the primary end point is not valued more than the secondary endpoints. One of the purposes of a phase 2 trial is to determine which endpoints should be continued in the phase 3, as well as which should be deemed the primary.
If we didnt meet the Primary (and I'm not convinced that is the case) the secondary endpoints will be used.
I can see a potential outcome where we didnt meet primary endpoint because the placebo group largely recovered by day 14. If that is the case, the PE will be discarded as it was flawed. The focus will be on early timeframe.
With that said, I keep thinking about the SAE. If the placebo had 2.5 times as many SAE, it stands to reason that there were a number of patients that did not fully recover in 14 days, so I still think the PE could be met.
If we didnt meet the Primary (and I'm not convinced that is the case) the secondary endpoints will be used.
I can see a potential outcome where we didnt meet primary endpoint because the placebo group largely recovered by day 14. If that is the case, the PE will be discarded as it was flawed. The focus will be on early timeframe.
With that said, I keep thinking about the SAE. If the placebo had 2.5 times as many SAE, it stands to reason that there were a number of patients that did not fully recover in 14 days, so I still think the PE could be met.
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