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RegisterTo pool or not to pool [Study Performance]
Dear Shankar,
Sounds a little bit strange to me to repeat a failed study without any modifications. IMHO it's dicing with the devil
(<-this one).
Of course its possible that the new study will result in success, because power (usually 80%) allows for failing to state bioequivalence only by chance. But that depends on the grade of failing.
I would opt for using at least some more subjects in the new study to increase power.
If the new study is done, you have two options in my opinion:
1. Pool the studies as Helmut has suggested. But check for regulatory acceptance. In Europe according to the new EMEA Draft it will not accepted. Here they want to see both results (not pooled). See this thread. Pooling does not necessary imply to recruit the same subjects.
2. If you have actually the same subjects, you could opt for a evaluation as a replicate design. But the wash-out phase between periods 2/3 of one year in comparison to the ordinary wash-out in each study questioned that approach. Regulatory acceptance? I couldn't guess
.
Sounds a little bit strange to me to repeat a failed study without any modifications. IMHO it's dicing with the devil
(<-this one).Of course its possible that the new study will result in success, because power (usually 80%) allows for failing to state bioequivalence only by chance. But that depends on the grade of failing.
I would opt for using at least some more subjects in the new study to increase power.
If the new study is done, you have two options in my opinion:
1. Pool the studies as Helmut has suggested. But check for regulatory acceptance. In Europe according to the new EMEA Draft it will not accepted. Here they want to see both results (not pooled). See this thread. Pooling does not necessary imply to recruit the same subjects.
2. If you have actually the same subjects, you could opt for a evaluation as a replicate design. But the wash-out phase between periods 2/3 of one year in comparison to the ordinary wash-out in each study questioned that approach. Regulatory acceptance? I couldn't guess
.—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- Same Volunteers In Two Different Studies shankar 2008-11-24 07:10
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Paired design Helmut 2008-11-24 14:32
- Paired design BE 2008-11-25 06:01
- Paired design d_labes 2008-11-25 10:06
- Paired design shankar 2008-11-25 06:50
- Repeated / previous study d_labes 2008-11-25 09:56
- Repeated / previous study shankar 2008-11-25 11:12
- To pool or not to poold_labes 2008-11-25 11:52
- Not to pool ;-) Helmut 2008-11-25 12:25
- Not to pool ;-) is best pooling d_labes 2008-11-25 13:14
- Not to pool is best billiards ;-) Helmut 2008-11-25 13:20
- Pool is to big d_labes 2008-11-25 13:28
- Not to pool is best billiards ;-) Helmut 2008-11-25 13:20
- Not to pool ;-) is best pooling d_labes 2008-11-25 13:14
- Not to pool ;-) Helmut 2008-11-25 12:25
- Repeated / previous study Ohlbe 2008-11-25 11:54
- Bioavailability Comparison shankar 2008-11-25 12:24
- Bioavailability Comparison Helmut 2008-11-25 12:29
- Bioavailability Comparison shankar 2008-11-25 12:45
- Non Regulatory Submission shankar 2008-11-29 07:06
- Bioavailability Comparison shankar 2008-11-25 12:45
- Bioavailability Comparison Helmut 2008-11-25 12:29
- Bioavailability Comparison shankar 2008-11-25 12:24
- To pool or not to poold_labes 2008-11-25 11:52
- Repeated / previous study shankar 2008-11-25 11:12
- Repeated / previous study d_labes 2008-11-25 09:56
- Paired design BE 2008-11-25 06:01
- Paired design Helmut 2008-11-24 14:32
Ing. Helmut Schütz