Pilot or pivotal ? [General Sta­tis­tics]

posted by jag009  – NJ, 2018-06-29 20:53 (817 d 03:04 ago) – Posting: # 19000
Views: 8,035

Hi Olhbe

» 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 ?
» 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 ?

Damn. We did pivotals 4-way crossover 3T vs R before! :surprised: R&D said no time and material was cheap! :confused: I said "Ooooookay..."

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