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Register6x3 design [Design Issues]
Dear All
We have a study that deals with One test drug and Two references. It is a pilot study comprising of 18 subjects. As far as I believe, we can go forward with a 6x3 design for the above study. But the sponsor has different thoughts. They want a 3x3 design with the same specifications? So is this feasible for a pilot study. Definitely a 3x3 design is good to ascertain results in a pivotal study but I do not think that same is the case in a pilot where you need a more balanced design. So what should be a valid design?
regards
Rajdeep
We have a study that deals with One test drug and Two references. It is a pilot study comprising of 18 subjects. As far as I believe, we can go forward with a 6x3 design for the above study. But the sponsor has different thoughts. They want a 3x3 design with the same specifications? So is this feasible for a pilot study. Definitely a 3x3 design is good to ascertain results in a pivotal study but I do not think that same is the case in a pilot where you need a more balanced design. So what should be a valid design?
regards
Rajdeep
—
Best regards
Rajdeep Mukherjee
Protocol Developer
Best regards
Rajdeep Mukherjee
Protocol Developer
Complete thread:
- 6x3 designRajdeep 2007-12-19 06:39 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 6x3 design Ohlbe 2007-12-19 09:59
- 6x3 design (not 3x3!!) Helmut 2007-12-19 13:16
- 6x3 design Ohlbe 2007-12-19 09:59
Ing. Helmut Schütz