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

posted by ElMaestro  – Denmark, 2020-03-24 10:07 (1518 d 01:12 ago) – Posting: # 21298
Views: 2,374

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?

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,033 posts in 4,835 threads, 1,642 registered users;
44 visitors (0 registered, 44 guests [including 9 identified bots]).
Forum time: 12:20 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

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