FDA grabbing data pre-top-line: Bigger picture?
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Posted On: 02/24/2021 4:22:48 PM
FDA grabbing data pre-top-line: Bigger picture?
M: time to recovery was the fifth FDA efficacy endpoint class in their update. That would fix the concern you note. I don't know if that info can be recovered from the official CD-12 locked data set.
Bigger picture: This new scenario of the FDA grabbing data before top line reports are out, and possibly creating new, more comparable, endpoints for all trials raises a host of issues.
Among them: I admit to have stated data base lock might come quickly, because so few data items played into calculating significance (I think it was 4 integers and 14 real numbers).
In this new world (if we see it right) a host of details might be reconfigured in new decision paradigms. The FDA might have had us spend time chasing data items we hadn't thought were relevant to data enter.
M: time to recovery was the fifth FDA efficacy endpoint class in their update. That would fix the concern you note. I don't know if that info can be recovered from the official CD-12 locked data set.
Bigger picture: This new scenario of the FDA grabbing data before top line reports are out, and possibly creating new, more comparable, endpoints for all trials raises a host of issues.
Among them: I admit to have stated data base lock might come quickly, because so few data items played into calculating significance (I think it was 4 integers and 14 real numbers).
In this new world (if we see it right) a host of details might be reconfigured in new decision paradigms. The FDA might have had us spend time chasing data items we hadn't thought were relevant to data enter.
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