Pilot or pivotal ? [General Sta­tis­tics]

posted by ElMaestro  – Belgium?, 2018-06-27 13:01 (882 d 08:49 ago) – Posting: # 18977
Views: 8,785

Hello Ohlbe

» Isn't the common practice to first test T1 and T2 vs. R in a pilot study (and I will not get into a debate on whether alpha correction would be needed), select one of the two test formulations, and then test it in a pivotal study in the usual way ? How often do you see both test formulations directly tested in a pivotal study ?

That's right. I have never seen an evaluation of two tests in a single study in which the applicant hoped for approval of both.

» OK, maybe if the product has a very low variability and the number of subjects remains very low, it could make sense and save time to directly go for the pivotal. Any experience ?

Yes absolutely. The majority of dossiers are being accepted without pilot trials. Whether to go for a pilot before a pivotal is dictated by many factors. First to file is a very significant one, but also involved is BCS class, budgets, previous failures ("You guys need to start showing some results!"), gut feeling and much more.
However I get slightly worried when you are suddenly allowing the term sense to enter this discussion. My empirical observation is that that term has absolutely no place in the planning of BE studies.:-D

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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