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RegisterTest/Reference Ratio [Power / Sample Size]
Dear all
If I want to calculate sample size based on a pilot study and if the pilot study Test/Reference ratio is more than 5%, for e.g Mean T/R=112%, can i include the same in my sample size calculation for pivotal study (contradictory to a null ratio of 0.95 or 1.00 which is being routinely applied in sample size calculation)?
Will this be acceptable from regulatory point of view?
If I want to calculate sample size based on a pilot study and if the pilot study Test/Reference ratio is more than 5%, for e.g Mean T/R=112%, can i include the same in my sample size calculation for pivotal study (contradictory to a null ratio of 0.95 or 1.00 which is being routinely applied in sample size calculation)?
Will this be acceptable from regulatory point of view?
Complete thread:
- Test/Reference Ratiodrplacebo 2008-09-12 11:41
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Test/Reference Ratio Ohlbe 2008-09-12 12:25
- Test/Reference Ratio Helmut 2008-09-19 17:11
- Test/Reference Ratio SKR 2008-10-03 09:08
Ing. Helmut Schütz