Stage 1 BE [Two-Stage / GS Designs]

posted by d_labes  – Berlin, Germany, 2011-08-23 16:51 (5008 d 02:20 ago) – Posting: # 7294
Views: 6,700

Dear BEman

❝ 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 :-D.
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 :cool:.

Regards,

Detlew

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