Pilot or pivotal ? [General Sta­tis­tics]

posted by jag009  – NJ, 2018-06-29 22:53 (2175 d 13:46 ago) – Posting: # 19000
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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..."
John

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