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RegisterLoss of power etc. [Design Issues]
Dear all!
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.
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%!
Funny thing, but the drugs were bioequivalent! Moreover they are bioequivalent nevetherless including drop-out's results or not! And that fact was already stated in the report. What to do in such a situation?
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.
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%!
Funny thing, but the drugs were bioequivalent! Moreover they are bioequivalent nevetherless including drop-out's results or not! And that fact was already stated in the report. What to do in such a situation?
—
"Being in minority, even a minority of one, did not make you mad"
"Being in minority, even a minority of one, did not make you mad"
Complete thread:
- Study conduct in groups Smitha 2015-02-02 04:21
![[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