Pilot or pivotal ? [General Sta­tis­tics]

posted by ElMaestro  – Denmark, 2018-06-27 15:01 (2154 d 15:08 ago) – Posting: # 18977
Views: 12,907

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

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,033 posts in 4,835 threads, 1,647 registered users;
41 visitors (0 registered, 41 guests [including 7 identified bots]).
Forum time: 06:10 CEST (Europe/Vienna)

Give me a fruitful error any time, full of seeds, bursting with its own corrections.
You can keep your sterile truth for yourself.    Vilfredo Pareto

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5