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Hi vasup,
Well, although your power goes up you might be unnecessarily exposing some subjects to the IMPs and this could be seen as problematic in terms of ethics. Also, you may see that some of your CIs become so narrow that 1.00 isn't included; this in itself is not too much of a regulatory problem unless you read Danish guidelines, but in practice some people seem to have a mental blockade about it. If I get it right promotional material mentioning actual CIs is said to be more efficient if the CI spans over 1.00 than if it doesn't.
❝ For example based on the calculation and to get required power 50 subjects are sufficient what will be fate of the study if i use 100 subjects. Is acceptable to regulatory agencies.
Well, although your power goes up you might be unnecessarily exposing some subjects to the IMPs and this could be seen as problematic in terms of ethics. Also, you may see that some of your CIs become so narrow that 1.00 isn't included; this in itself is not too much of a regulatory problem unless you read Danish guidelines, but in practice some people seem to have a mental blockade about it. If I get it right promotional material mentioning actual CIs is said to be more efficient if the CI spans over 1.00 than if it doesn't.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Sample size vasup 2013-07-29 08:37
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- Sample sizeElMaestro 2013-07-29 10:00
- Sample size jag009 2013-07-29 15:57
- Overpowering Helmut 2013-07-30 15:51
- Overpowering ElMaestro 2013-07-30 16:37
- Overpowering jag009 2013-07-30 16:45
- Overpowering ElMaestro 2013-07-30 16:51
- Overpowering jag009 2013-08-01 20:08
- Overpowering kumarnaidu 2013-09-02 12:22
- Conservative study planning Helmut 2013-09-02 12:42
- Conservative study planning kumarnaidu 2013-09-02 14:36
- Conservative study planning Ohlbe 2013-09-02 18:44
- confidence limit of the CV Jay 2013-09-06 13:55
- CL of CV Helmut 2013-09-06 15:02
- CL of CV Jay 2013-09-06 15:21
- CL of CV Helmut 2013-09-06 15:42
- PE consideration Jay 2013-09-11 11:02
- PE consideration Dr_Dan 2013-09-11 12:07
- PE consideration Jay 2013-09-11 13:09
- PE consideration kumarnaidu 2013-09-11 13:22
- Sockpuppet? Helmut 2013-09-11 14:13
- PE consideration kumarnaidu 2013-09-12 13:04
- PE consideration Dr_Dan 2013-09-11 12:07
- PE consideration Jay 2013-09-11 11:02
- CL of CV Helmut 2013-09-06 15:42
- CL of CV Jay 2013-09-06 15:21
- CL of CV Helmut 2013-09-06 15:02
- Conservative study planning kumarnaidu 2013-09-02 14:36
- Conservative study planning Helmut 2013-09-02 12:42
- Overpowering kumarnaidu 2013-09-02 12:22
- Overpowering jag009 2013-08-01 20:08
- Overpowering ElMaestro 2013-07-30 16:51
- Overpowering jag009 2013-07-30 16:45
- Overpowering ElMaestro 2013-07-30 16:37
Ing. Helmut Schütz