2:1 allocation [General Sta­tis­tics]

posted by msmnainar – India, 2021-06-23 16:49 (334 d 03:10 ago) – Posting: # 22428
Views: 755

Hi Helmut,

Thanks for your detailed explanation.

» » Note: The 2:1 randomization is mainly due to transition arm.
»
» What do you mean by that?

Transition arm is in general re-randomization at certain week after efficacy evaluation (FDA requirement).

Basically, 1:1 randomization allocation would lead to a larger sample size for subjects transitioning from Reference to Test, which would allow for detecting differences in immunogenicity and safety.

Sundar. M

Complete thread:

UA Flag
Activity
 Admin contact
22,092 posts in 4,630 threads, 1,567 registered users;
online 18 (0 registered, 18 guests [including 10 identified bots]).
Forum time: Monday 19:59 CEST (Europe/Vienna)

There is no adequate defense, except stupidity,
against the impact of a new idea.    Percy Williams Bridgman

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