Give sequence a chance [General Sta­tis­tics]

posted by d_labes  – Berlin, Germany, 2009-12-11 10:42 (6039 d 21:33 ago) – Posting: # 4466
Views: 11,430

Dear Stefano,

❝ Probably, if we assume that carryover of higher order are extremely unlikely, its interpretation is analogous to that given in 2x2 design.


Not at least: Occurred simply by chance! Since and if it is extremely unlikely. See:

Stephen Senn, Giuseppina D’Angelo, and Diane Potvin
"Carry-over in cross-over trials in bioequivalence: theoretical concerns and empirical evidence"
Pharmaceut. Statist. 2004; 3: 133–142

But I guess, you know that? :-)

Astonishing enough this is already mentioned in the 1997 FDA guidance:
"IV. Sequence effect
... Even if there were no true sequence effect, no unequal residual effect (aka carryover) and no period-by-treatment statistical interaction, approximately ten out of every hundred standard two-treatment crossover studies would be likely to show an apparent sequence effect, if the testing is carried out at the ten percent level of significance. ..."


❝ ... What I am really interested in is the rationale behind this "common practice".


Like Helmut I'm convinced that this is definitely a historical leftover.
But regulated by law. Because we/other/people[1] tend to take guidances in the field of medical research as law.
[1] Please delete where inapplicable.

Regards,

Detlew

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