2:1 allocation [General Sta­tis­tics]

posted by msmnainar – India, 2021-06-23 16:49 (33 d 08:41 ago) – Posting: # 22428
Views: 278

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

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