Pilot or pivotal ? [General Sta­tis­tics]

posted by ElMaestro  – Belgium?, 2018-06-27 14:48 (882 d 06:54 ago) – Posting: # 18979
Views: 8,688

Hi Ohlbe,

» Sure, when you only have one test formulation. But when you hesitate between two ? Would you directly go for a pivotal where both test formulations would be compared to the reference, and then file whichever one passes ?

This is purely hypothetical for me. As far as I recall, I have not ever faced such a situation where two test formulations targeting the same authority were heads-on compared in a pivotal trial. I have faced it numerous times in pilot trials, but here the choice of formulation rarely is based on the CI but just on the observed GMR.

If I were in a situation, hypothetically, where I had one pivotal trial with two passing T formulations against a single, and I only needed one approval, then I am not sure what I would base my choice on. It could be cost of goods, or a risk-based assessment of the manufacturing bottlenecks for the two T formulations. Not sure, I have a feeling this would not be science-driven but Guy-in-Armani-suit-driven.

I could be wrong, but...

Best regards,

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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