higher order crossover methodology [General Sta­tis­tics]

posted by ElMaestro  – Denmark, 2020-06-30 20:17 (1826 d 14:42 ago) – Posting: # 21623
Views: 9,239

Ah,

it is all coming together now.

Thanks sweiner,
this is a great question.:-)

❝ In a 5-way BE crossover trial, is there a methodology available that allows one to analyze 3 out of 5 sequences for BE in an interim fashion, and contingent upon results complete the remaining 2 sequences and analyze all 5 sequences at the conclusion?


Should read: "In a 5-way BE crossover trial, is there a methodology available that allows one to analyze 3 out of 5 periods for BE in an interim fashion, and contingent upon results complete the remaining 2 periods and analyze all 5 periods at the conclusion?"

This is an interesting idea, one that has not been explored much yet in the public domain; I think a few other sponsors have used it.
It is definitely doable as a single protocol. It is in fact what other companies / sponsors are achieving with two separate studies. Just do it, I think it may not require much operational adjustment or statistical fiddling, unless you can say you will switch to another formulation and re-start another 5-period trial once the first formulation fails after 3 periods.

A great post, in my opinion.

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,425 posts in 4,928 threads, 1,680 registered users;
108 visitors (0 registered, 108 guests [including 44 identified bots]).
Forum time: 10:59 CEST (Europe/Vienna)

Fools with Tools Are Still Fools!    Anonymous

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