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Registerhigher order crossover methodology [General Statistics]
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.
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
Pass or fail!
ElMaestro
Complete thread:
- higher order crossover methodology sweiner 2020-06-30 01:07 [General Statistics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- All dosed subjects have to be analyzed Helmut 2020-06-30 12:19
- All dosed subjects have to be analyzed sweiner 2020-06-30 17:08
- All dosed subjects have to be analyzed sedhosen 2021-03-16 08:30
- All dosed subjects have to be analyzed Helmut 2021-03-16 16:00
- higher order crossover methodology Relaxation 2020-06-30 14:10
- higher order crossover methodology sweiner 2020-06-30 17:10
- higher order crossover methodologyElMaestro 2020-06-30 18:17
- Fed (IBD) → fasting Helmut 2020-07-01 11:14
- Fed (IBD) → fasting sweiner 2020-07-07 03:00
- Fed (IBD) → fasting Helmut 2020-07-01 11:14
- higher order crossover methodologyElMaestro 2020-06-30 18:17
- higher order crossover methodology sweiner 2020-06-30 17:10
- All dosed subjects have to be analyzed Helmut 2020-06-30 12:19
Ing. Helmut Schütz