Statistical analysis in group sequential study [Two-Stage / GS Designs]

posted by rafimmc – 2007-06-19 12:59 (6942 d 12:08 ago) – Posting: # 819
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Dear Sir,
We are planning to conduct a study using group sequential design. I have two questions in this.
  1. Do we have to calculate 95% only? or Calculate 90% first and if study fails, go for 95% and add on more subjects.
  2. We have two test products (i.e 3 way study). If the study fails, we want to take only one test product (with better profile) for the second stage with add on subjects. So the second stage would become two way.
    Now we have to combine two stages for final statistical analysis to calculate 95% CI. Please help me a way out!
Thanks and regards,
Rafimmc

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