msmnainar ★ India, 2021-06-22 16:24 (1009 d 21:58 ago) Posting: # 22426 Views: 1,982 |
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Hello all, Need your expert opinion on the following, Will there be any issue in adopting 2:1 (Test:Reference) randomization method in biosimilarity (BE) studies? Note: The 2:1 randomization is mainly due to transition arm. — Sundar. M |
Helmut ★★★ Vienna, Austria, 2021-06-22 17:05 (1009 d 21:16 ago) @ msmnainar Posting: # 22427 Views: 1,579 |
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Hi Sundar, welcome back to the forum! ❝ Will there be any issue in adopting 2:1 (Test:Reference) randomization method in biosimilarity (BE) studies? You will loose some power compared to equally sized treatment arms. For an -script see there. It gives for an assumed CV 40% and T/R-ratio 0.95 targeted at 80% power:
❝ Note: The 2:1 randomization is mainly due to transition arm. What do you mean by that? — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
msmnainar ★ India, 2021-06-23 18:49 (1008 d 19:32 ago) @ Helmut Posting: # 22428 Views: 1,534 |
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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 |