(Total Views: 454)
Posted On: 02/24/2021 4:22:48 PM
Post# of 153919
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.
(3)
(0)
