Which GMR to plug in [Two-Stage / GS Designs]

posted by ElMaestro  – Belgium?, 2017-02-21 10:47  – Posting: # 17095
Views: 10,395

Hi BE-proff,

» I suppose you are talking about futility studies as a alternative for adaptive designs.

Errr.... what????

» Why are futility designs more popular if risks are similar? :confused:

Come again, what does this mean?
What is a futility design, futility study, how are they alternatives?


I meant to say that plugging in the observed GMR has a bunch of drawbacks, which often are plain showstoppers. The sample size explosion can be fixed by futility caps on sample size, and that of course keeps the sample size (and cost) down, but then power may be so low that the trial makes no sense and is nothing more than unethical exposure.

2-stage trials work well then you are absolutely sure about the match and only unsure about the variability.

I could be wrong, but...

Best regards,
ElMaestro

"Pass or fail" (D. Potvin et al., 2008)

Complete thread:

Activity
 Admin contact
20,793 posts in 4,353 threads, 1,445 registered users;
online 9 (0 registered, 9 guests [including 2 identified bots]).
Forum time: 20:41 UTC (Europe/Vienna)

Genius is that which forces
the inertia of humanity to learn.    Henri Bergson

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