“Spare subjects”, multiple groups [Regulatives / Guidelines]

posted by Peregrin – Russia, 2015-07-25 16:31 (3486 d 13:58 ago) – Posting: # 15145
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❝ Whether or not you have to modify the statistical model is a gray zone. Search the forum for “group effect”.

❝ See also FDA’s 2001 guidance, Section VII.A.


Dear Helmut,

Thank you so much! This is the exact thing I've been looking for!
Several more questions have arised when I was considering your answer:
Should the sponsor explicitly state in the protocol that the study for logistical reasons will be carried out in two or more groups?
If the study has been conducted in several groups without statistical arrangements, should the sponsor at least provide some reasons for not doing so?

Kind regards,
Peregrin

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