protocol amendment that may trigger Group effect test [General Sta­tis­tics]

posted by ElMaestro  – Belgium?, 2020-03-24 09:07 (134 d 23:20 ago) – Posting: # 21298
Views: 1,121

Hi Silke,

» Situation:
» 1st period was dosed in 1 group and completed in CRO 1
» 2nd period must now be performed at a different CRO (CRO 2)
» 2nd period must be performed in 2 groups in CRO 2

That's annoying :-)

» Protocol amendment:
» Switch in CRO including all tasks
» due to the change of dosing in 1 group to 2 groups in period 2 the washout will be different between the two groups.
»
» Does this trigger the evaluation of a group effect, although the groups may only be separated by 1 week?
»
» Is there special statistics we need to consider to address this properly?

In my opinion it is not overly informative to do a group analysis here, at least not within the fit which provides for the evaluation of BE (here it is a kind of "accidental group within period within CRO", where period somehow is indistinguishable from CRO :surprised::ponder:).

Can you switch the volunteers to the other CRO, or has it become a parallel trial rather than a crossover trial by now?

I could be wrong, but...

Best regards,
ElMaestro

"Pass or fail" (D. Potvin et al., 2008)

Complete thread:

Activity
 Admin contact
20,969 posts in 4,374 threads, 1,461 registered users;
online 13 (0 registered, 13 guests [including 12 identified bots]).
Forum time: Thursday 09:28 CEST (Europe/Vienna)

It is a good morning exercise for a research scientist
to discard a pet hypothesis every day before breakfast.
It keeps him young.    Konrad Lorenz

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5