I wouldn’t be surprised if the interim analysis
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Posted On: 04/22/2020 12:36:29 PM
I wouldn’t be surprised if the interim analysis is done on the primary endpoint first, which would mean 50 patients through four weeks. I hope they can look after 14, but that’s a secondary endpoint. Perhaps someone with more intimate knowledge of study design and execution could provide some clarity from their experience?
As an example, I’m using what just happened with Acasti. They were going to announce secondary endpoints of their two recent phase 3 trials (Last Dec/Jan) only after successfully achieving and announcing the results of their primary endpoint. When their first study had a high placebo effect and couldn’t show statistical significance they never moved toward secondary endpoint analysis. Or just never did it with an eye on publishing results. Might be a similar thing we see here. 14 would be great but they may only want to look at 28 first.
As an example, I’m using what just happened with Acasti. They were going to announce secondary endpoints of their two recent phase 3 trials (Last Dec/Jan) only after successfully achieving and announcing the results of their primary endpoint. When their first study had a high placebo effect and couldn’t show statistical significance they never moved toward secondary endpoint analysis. Or just never did it with an eye on publishing results. Might be a similar thing we see here. 14 would be great but they may only want to look at 28 first.
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