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Registercortisol suppression as clinical endpoint [Design Issues]
Dear lizhao,
The first suggestion is a potential winner. You'll always have pre-dose samples so no reason not to address the baseline in it.
But on the other hand, what do you know about wash-out and potential for carryover? Some companies lean towards parallel designs. It is a very complicated matter.
My sixth sense tells me you might be working on an inhaled formulation? In that case, to be honest: At the moment many, many, many companies including some from the world's top 10 are outright failing their Cortisol suppression studies even though they have invested lots and lots of resources in formulations, good CROs (actually they seem to pick cheap ones over good ones) and expensive experts to help them. The literature is no help, you will not see what doesn't work in papers. So take my advice: Don't do it. If you are in a situation where your formulation needs a CS study there is probably a reason behind it such as a failed safety PK study, a desire for a children's indication or other stuff which just spells trouble.
❝ I can think of two kinds of study designs:
❝ 1. baseline1 → Test treatment → washout period → baseline2 → Reference treatment
❝
❝ 2. baseline → Test treatment → Reference treatment
The first suggestion is a potential winner. You'll always have pre-dose samples so no reason not to address the baseline in it.
But on the other hand, what do you know about wash-out and potential for carryover? Some companies lean towards parallel designs. It is a very complicated matter.
My sixth sense tells me you might be working on an inhaled formulation? In that case, to be honest: At the moment many, many, many companies including some from the world's top 10 are outright failing their Cortisol suppression studies even though they have invested lots and lots of resources in formulations, good CROs (actually they seem to pick cheap ones over good ones) and expensive experts to help them. The literature is no help, you will not see what doesn't work in papers. So take my advice: Don't do it. If you are in a situation where your formulation needs a CS study there is probably a reason behind it such as a failed safety PK study, a desire for a children's indication or other stuff which just spells trouble.
❝ Can somebody tell me which one is the right one? If either one is correct, can you please tell me the study design recommended by EMA or FDA?
- Don't do it.
- If you ignore pt. 1, then at least take scientific advice / protocol assistance at the authority to get the design right. If your boss tells you that there is no time or no budget for it, then you need a new boss.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- cortisol suppression as clinical endpoint lizhao 2014-09-10 23:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- cortisol suppression as clinical endpointElMaestro 2014-09-10 23:42
- cortisol suppression as clinical endpoint nobody 2014-09-11 08:45
- cortisol suppression as clinical endpoint lizhao 2014-09-11 23:00
- cortisol suppression as clinical endpoint nobody 2014-09-12 13:59
- cortisol suppression as clinical endpoint ElMaestro 2014-09-12 14:56
- cortisol suppression as clinical endpoint nobody 2014-09-12 16:00
- cortisol suppression as clinical endpoint lizhao 2015-11-12 02:15
- cortisol suppression as clinical endpoint nobody 2015-11-12 08:27
- cortisol suppression as clinical endpoint lizhao 2015-11-12 11:07
- cortisol suppression as clinical endpoint nobody 2015-11-12 16:06
- cortisol suppression as clinical endpoint ElMaestro 2015-11-13 18:39
- cortisol suppression as clinical endpoint lizhao 2015-11-13 20:56
- cortisol suppression as clinical endpoint lizhao 2015-12-02 23:00
- cortisol suppression as clinical endpoint lizhao 2015-11-12 11:07
- cortisol suppression as clinical endpoint nobody 2015-11-12 08:27
- cortisol suppression as clinical endpoint lizhao 2015-11-12 02:15
- cortisol suppression as clinical endpoint nobody 2014-09-12 16:00
- cortisol suppression as clinical endpoint ElMaestro 2014-09-12 14:56
- cortisol suppression as clinical endpoint nobody 2014-09-12 13:59
- cortisol suppression as clinical endpoint lizhao 2014-09-11 23:00
Ing. Helmut Schütz