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RegisterLoss of power etc. [Design Issues]
Hi Astea,
It is an extremely unfortunate situation, and the regulators have clearly misunderstood the use of power, what it is and what it isn't. It is tempting to think that a study that passes the BE test must have a high power but this argument is just flawed. I am really sorry to hear you are caught in this mess.
Very often companies that really do use posthoc power in their reporting do not use the observed GMR but rather plug in something like 0.95 or 1.00. This of course often give rise to higher power estimates, ones that arguably have little to do with anything. Perhaps that is your chance? Let me add, I do not in any way endorse such power calculation but then again I do not know what the regulator wants with a posthoc power calculation in the first place, so who knows?!?
Good luck, let us know how this ends, please.
❝ I understand clear that post-hoc power is set yours teeth on edge, but I'll take a chance to ask a question once more... There was a study with one drop-out. The results of that subject have not been included in the calculation. Recently the customers received a reply from regulatories to calculate aposteriory power and in the case of insufficient power present a plan for further clinical development of the drug.
It is an extremely unfortunate situation, and the regulators have clearly misunderstood the use of power, what it is and what it isn't. It is tempting to think that a study that passes the BE test must have a high power but this argument is just flawed. I am really sorry to hear you are caught in this mess.
❝ I estimated power with the help of power.TOST, based on obtained GMR and CV. The result is: power is less than 80% for AUC and more than 80% for Cmax. I remade the calculation including the drop-out: power for AUC is still less than 80%!
Very often companies that really do use posthoc power in their reporting do not use the observed GMR but rather plug in something like 0.95 or 1.00. This of course often give rise to higher power estimates, ones that arguably have little to do with anything. Perhaps that is your chance? Let me add, I do not in any way endorse such power calculation but then again I do not know what the regulator wants with a posthoc power calculation in the first place, so who knows?!?
Good luck, let us know how this ends, please.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Study conduct in groups Smitha 2015-02-02 04:21 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Study conduct in groups ElMaestro 2015-02-02 08:21
- Study conduct in groups Helmut 2015-02-02 13:08
- Study conduct in groups Smitha 2015-02-04 04:30
- Study conduct in groups Helmut 2015-02-04 12:57
- Study conduct in groups felipeberlinski 2015-02-04 22:36
- Study conduct in groups ElMaestro 2015-02-04 23:58
- Significant ≠ relevant Helmut 2015-02-05 00:49
- Significant ≠ relevant Astea 2016-03-24 20:10
- Significant ≠ relevant ElMaestro 2016-03-24 23:12
- Significant ≠ relevant zizou 2016-03-25 21:41
- Loss of power etc. Helmut 2016-03-26 14:46
- Loss of power etc. Astea 2016-03-27 21:18
- Loss of power etc. zizou 2016-03-27 23:44
- Combined power? Helmut 2016-03-28 14:29
- Loss of power etc. Astea 2016-03-28 23:57
- Loss of power etc.ElMaestro 2016-03-29 00:16
- Mystery Helmut 2016-03-29 17:28
- Back to the Future Astea 2016-03-29 21:57
- Back to the Future ElMaestro 2016-03-29 23:11
- Using lectures != Reading them mittyri 2016-03-30 00:17
- Back to the Future ElMaestro 2016-03-29 23:11
- Back to the Future Astea 2016-03-29 21:57
- Loss of power etc. Helmut 2016-03-26 14:46
- Significant ≠ relevant Astea 2016-03-24 20:10
- Study conduct in groups felipeberlinski 2015-02-04 22:36
- Study conduct in groups Helmut 2015-02-04 12:57
- Study conduct in groups Smitha 2015-02-04 04:30
Ing. Helmut Schütz