Deficiencies [Power / Sample Size]
Dear All.
Ignoring the risk that I may got it totally wrong, but from my experience (as a non-statistician
) another phenomenon of doublethink may fit to
In current discussions on this topic the general opinion around here is quite clear: testing more than one option vs. Reference is multiple testing because you have "more than one shot" → adjust the ALPHA.
On the other hand, in reality more often than not, sponsors will then simply conduct two studies. I was never brave enough to comment, that this would be "more than one shoot", too, and we should adjust the ALPHA in each study.
But seriously, why should testing alternatives in one study require a punishment and testing in seperate studies not. Because I pay my fee in doubled overhead study costs? Or because I don't have to tell anybody of the "other study" during application
?
Best regards,
Relaxation.
Ignoring the risk that I may got it totally wrong, but from my experience (as a non-statistician

❝ Point 2. In the light of the combination of two BE statements (tablet vs. reference or capsule vs. reference) this is combination with OR. If, and only if a global statement is here appropriate. IMHO here both hypotheses are standing for it's own.
In current discussions on this topic the general opinion around here is quite clear: testing more than one option vs. Reference is multiple testing because you have "more than one shot" → adjust the ALPHA.
On the other hand, in reality more often than not, sponsors will then simply conduct two studies. I was never brave enough to comment, that this would be "more than one shoot", too, and we should adjust the ALPHA in each study.

But seriously, why should testing alternatives in one study require a punishment and testing in seperate studies not. Because I pay my fee in doubled overhead study costs? Or because I don't have to tell anybody of the "other study" during application

Best regards,
Relaxation.
Complete thread:
- Sample size for 4-period 4-sequence crossover BE study Bryony Simmons 2018-02-01 12:16 [Power / Sample Size]
- function sampleN.TOST of package PowerTOST Helmut 2018-02-01 13:01
- Alpha adjustment in higher order crossover d_labes 2018-02-01 14:01
- Deficiencies Helmut 2018-02-01 15:48
- Deficiencies nobody 2018-02-01 17:10
- Deficiencies d_labes 2018-02-01 18:57
- DeficienciesRelaxation 2018-02-02 11:12
- Deficiencies nobody 2018-02-02 12:49
- Deficiencies Helmut 2018-02-02 16:14
- Deficiencies Relaxation 2018-02-02 19:41
- alpha... where is omega? Astea 2018-02-02 21:45
- α and no ω Helmut 2018-02-02 23:39
- TIE for NTIDs d_labes 2018-02-04 12:40
- TIE for NTIDs Astea 2018-02-04 20:04
- TIE for NTIDs Helmut 2018-02-05 01:01
- TIE for NTIDs d_labes 2018-02-05 16:40
- TIE for NTIDs Helmut 2018-02-05 17:49
- TIE for NTIDs d_labes 2018-02-05 22:17
- TIE for NTIDs Helmut 2018-02-06 12:34
- TIE for NTIDs d_labes 2018-02-05 22:17
- TIE for NTIDs Helmut 2018-02-05 17:49
- TIE for NTIDs d_labes 2018-02-05 16:40
- TIE for NTIDs d_labes 2018-02-05 16:35
- bow TIE for NTIDs Astea 2018-02-05 17:52
- bow TIE for NTIDs Helmut 2018-02-05 18:10
- 111.11 for NTIDs Astea 2018-02-05 19:27
- 111.11 for NTIDs Helmut 2018-02-06 00:12
- 111.11 for NTIDs Astea 2018-02-05 19:27
- bow TIE for NTIDs d_labes 2018-02-05 22:33
- bow TIE for NTIDs Helmut 2018-02-05 18:10
- bow TIE for NTIDs Astea 2018-02-05 17:52
- TIE for NTIDs Helmut 2018-02-05 01:01
- TIE for NTIDs Astea 2018-02-04 20:04
- TIE for NTIDs d_labes 2018-02-04 12:40
- α and no ω Helmut 2018-02-02 23:39
- alpha... where is omega? Astea 2018-02-02 21:45
- Deficiencies Relaxation 2018-02-02 19:41
- DeficienciesRelaxation 2018-02-02 11:12
- Deficiencies Helmut 2018-02-01 15:48
- Alpha adjustment in higher order crossover d_labes 2018-02-01 14:01
- function sampleN.TOST of package PowerTOST Helmut 2018-02-01 13:01