Bioequivalence and Bioavailability Forum • Statistical analysis in group sequential study

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

posted by rafimmc – 2007-06-19 12:59 (6577 d 22:56 ago) – Posting: # 819
Views: 9,730

Dear Sir,
We are planning to conduct a study using group sequential design. I have two questions in this.

Do we have to calculate 95% only? or Calculate 90% first and if study fails, go for 95% and add on more subjects.
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

Complete thread:

Statistical analysis in group sequential studyrafimmc 2007-06-19 10:59
- Add-On vs. group sequential design Helmut 2007-06-19 13:49
  - Add-On vs. group sequential design rafimmc 2007-07-12 11:12
    - Add-On vs. group sequential design Helmut 2007-07-12 16:08
  - Sequential Designs: recent paper Helmut 2007-09-05 17:35

Admin contact
23,424 posts in 4,927 threads, 1,673 registered users;
62 visitors (0 registered, 62 guests [including 12 identified bots]).
Forum time: 11:55 CEST (Europe/Vienna)

Medical researches can be divided into two sorts:
those who think that meta is better and those
who believe that pooling is fooling. Stephen Senn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz