2:1 allocation [General Sta­tis­tics]

posted by msmnainar – India, 2021-06-23 18:49 (595 d 16:46 ago) – Posting: # 22428
Views: 1,077

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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