Stage 1 BE [Two-Stage / GS Designs]
Dear BEman
Never is not a valid term to use in statistics
.
If you perform a 2-stage study with 12 subjects in the 'pilot' stage 1 and your intra-subject CV comes out between 10%-15% and your point estimate is ok, your sample size estimation for the total sample size will give you N=8...12 (BE acceptance range 0.8 ... 1.25, GMR=0.95, alpha=0.049 Haybittle-Peto, target power=80%).
I.e. you have supposedly reached BE in stage 1 with with a probability bordering on certainty
.
❝ Because I never reach BE in stage 1 (CV to high, CI will be wider than the acceptance range) I shouldn't have an alpha-inflation.
Never is not a valid term to use in statistics

If you perform a 2-stage study with 12 subjects in the 'pilot' stage 1 and your intra-subject CV comes out between 10%-15% and your point estimate is ok, your sample size estimation for the total sample size will give you N=8...12 (BE acceptance range 0.8 ... 1.25, GMR=0.95, alpha=0.049 Haybittle-Peto, target power=80%).
I.e. you have supposedly reached BE in stage 1 with with a probability bordering on certainty

—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- two stage design beman 2011-08-22 15:34
- two stage design ElMaestro 2011-08-22 16:58
- two stage design Helmut 2011-08-22 17:35
- two stage design beman 2011-08-23 12:37
- Stage 1 BEd_labes 2011-08-23 14:51
- two stage design beman 2011-08-23 12:37
- two stage design extreme d_labes 2011-08-23 13:46