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Posted On: 02/25/2021 12:32:24 PM
Post# of 151830

A simple example would be cd10 . Not enough of the people were sick enough .Bigger numbers more power , more than likely enough patients being sick to gauge recovery or not .
“””””In regards to power I’ve always wondered this:
Why would the FDA authorize a trial design that at full enrollment isn’t considered “powerful” enough at a resulting p-value of .05 (industry standard for p-value “success”) when both the company and the FDA are involved from the get go? I’d get falling short of power at a 50% or 75% interim analysis and requiring a stronger p-value result to consider it a success worth stopping early, but what’s the point of carefully designing a trial that does exactly what it’s supposed to do and “fails” to meet power? “”””
“””””In regards to power I’ve always wondered this:
Why would the FDA authorize a trial design that at full enrollment isn’t considered “powerful” enough at a resulting p-value of .05 (industry standard for p-value “success”) when both the company and the FDA are involved from the get go? I’d get falling short of power at a 50% or 75% interim analysis and requiring a stronger p-value result to consider it a success worth stopping early, but what’s the point of carefully designing a trial that does exactly what it’s supposed to do and “fails” to meet power? “”””


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