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Saturday, December 03, 2005 5:27:01 PM
>Either the methodology of Cox Regression is valid or it isn't regardless of the amount of change in p value.<
In theory, yes; in practice, no.
If I were a reviewer at the FDA or another regulatory body, I would tell any company that comes to me with a raw p-value of 0.33 and a Cox-adjusted p-value of 0.02 to redo the trial and come back with clean data. Even if it’s a supporting trial. (Or a pivotal trial masquerading as a “supporting” one
.)
In other words, I stand by the fine-tuning radio knob as the proper way to think about Cox from a practical standpoint.
In theory, yes; in practice, no.
If I were a reviewer at the FDA or another regulatory body, I would tell any company that comes to me with a raw p-value of 0.33 and a Cox-adjusted p-value of 0.02 to redo the trial and come back with clean data. Even if it’s a supporting trial. (Or a pivotal trial masquerading as a “supporting” one
.) In other words, I stand by the fine-tuning radio knob as the proper way to think about Cox from a practical standpoint.
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