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Register2:1 allocation [General Statistics]
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.
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.
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Sundar. M
Sundar. M
Complete thread:
- Randomization msmnainar 2021-06-22 14:24 [General Statistics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 2:1 allocation Helmut 2021-06-22 15:05
- 2:1 allocationmsmnainar 2021-06-23 16:49
- 2:1 allocation Helmut 2021-06-22 15:05
Ing. Helmut Schütz