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Posted On: 11/11/2020 5:11:47 PM
Post# of 148899
Re: Evil Rabbit #65162
Nobody knows if 293 is enough. We certainly hope so, but it's a guess. IMO, here's how they should play it- get to 293 and have the DSMC do the analysis at 42 days without unblinding. That part is obvious because we have to wait for that period of time plus data check/report. Hopefully we get the recommendation to halt at that time. Either way, what we absolutely cannot do is repeat what happened at 50%, and that was become lazy about recruiting. I don't know whether they thought they would unblind at 195 or what, but the 7 weeks between hitting 195 and the DSMC report were terrible. Recruiting slowed to a halt when it was actually gaining momentum up to 195. So even if we aren't told to halt, if we are aggressively recruiting from 293 up to the 42-60 days it takes to gather and analyze data, then we are probably approaching 390 and can have a better Plan B.
Like others, I am really intrigued by the recommendation to take another look.
Like others, I am really intrigued by the recommendation to take another look.
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