please explain your opinion regarding ICH E9 [Regulatives / Guidelines]

posted by mittyri – Russia, 2016-08-29 17:12 (3091 d 13:23 ago) – Posting: # 16609
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Hi David,

could you please explain this:

❝ According to ICH E9:

❝ "The main treatment effect may be investigated first using a model which allows for centre differences, but does not include a term for treatment-by-centre interaction. <...>"


❝ The model would include centre, centre*form and subject(sequence*centre).

centre*form - does that mean Centre*Formulation? If yes, doesn't it contradict the cite above?

ElMaestro suggested just to add the group effect

Kind regards,
Mittyri

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