Group effect, did you miss it? [General Sta­tis­tics]

posted by Astea – Russia, 2019-12-21 14:12  – Posting: # 21011
Views: 1,819

Dear Friends!

Recently I've known that Belorussian experts referring to EAEC rules require to recalculate the results of large studies using FDA's Model II, that is: Group, Sequence, Treatment, Period(Group), Group×Sequence as fixed and Subject(Group×Sequence) as Random though it was not stated in protocol beforehand.

I don't think it is a good idea. Moreover it could be contagious! What do you think about it?

Critical points: as standard model requires Sequence, Treatment, Period and Subject(Sequence) as fixed terms, the results of the random effect model obviously will be different. What if they will change the overall result of BE? What if the Group×Sequence effect would be significant by chance?

How to deal with excluded subjects? For example, if we have a subject with only one period the fixed-effect model would automatically neglect it while the random-effect model would use it.

As I understand currently it is impossible to calculate it via R, isn't it? May be Julia will help? So only people with commercial software could deal with it.

"Being in minority, even a minority of one, did not make you mad"

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