Pilot or pivotal ? [General Sta­tis­tics]

posted by Ohlbe – France, 2018-06-27 12:14 (1260 d 00:13 ago) – Posting: # 18975
Views: 10,915

Dear all,

» You want to get either T1 or T2 approved.

T1 = R T2 = R: ⇒ 95% CI

In this case I argued for no adjustment (90% CI) in the past but nowadays I’m leaning towards an adjustment because which one will be marketed is part of a decision tree.

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 ?

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
21,788 posts in 4,557 threads, 1,548 registered users;
online 12 (0 registered, 12 guests [including 4 identified bots]).
Forum time: Wednesday 11:27 CET (Europe/Vienna)

There is no adequate defense, except stupidity,
against the impact of a new idea.    Percy Williams Bridgman

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