Adaptive design - glad to see CD-12 has that in th
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Posted On: 07/09/2020 4:43:55 PM
Adaptive design - glad to see CD-12 has that in the clinicaltrials.gov description. Per the FDA document (thanks!), that means the criteria for an early read-out were prospectively-agreed, complete with auxiliary statistics analysis plans, indicating it should be on auto-pilot, though we don't know those details.
Most interesting subtlety: the interim review would look at "treatment A" vs. "treatment B," making comparisons that don't formally have info which is leronlimab.
NP has also used the phrase: "calling a data safety monitoring board meeting." I don't know if that is meant to be under this guidance or is separate. I think I heard a DSMB ends the study immediately.
Most interesting subtlety: the interim review would look at "treatment A" vs. "treatment B," making comparisons that don't formally have info which is leronlimab.
NP has also used the phrase: "calling a data safety monitoring board meeting." I don't know if that is meant to be under this guidance or is separate. I think I heard a DSMB ends the study immediately.
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