Nonbinding futility rule [Two-Stage / GS Designs]

posted by d_labes  – Berlin, Germany, 2018-06-13 16:59 (948 d 03:47 ago) – Posting: # 18900
Views: 11,675

Dear Ben,

» General remark here: In your example we see that BE has not been achieved only marginally. The Repeated CI is (0.79215, 0.99993). Even though the power of stage 1 is large enough so that we formally conclude futility, one could question whether it is really a good idea to stop the trial due to futility ...

If I see it correctly that's called in Maurer et al. "futility rule can be applied in a nonbinding manner, ie, it can be used as guidance but must not necessarily be followed." (page 19, bottom)
How to obtain a sample size number for the second stage if we want to do so?

Regards,

Detlew

Complete thread:

Activity
 Admin contact
21,303 posts in 4,441 threads, 1,487 registered users;
online 9 (0 registered, 9 guests [including 7 identified bots]).
Forum time: Saturday 19:46 CET (Europe/Vienna)

If you can’t solve a problem, then there is an easier problem
you can solve: find it.    George Pólya

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5