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

posted by ElMaestro  – Denmark, 2020-03-24 10:07 (1039 d 12:29 ago) – Posting: # 21298
Views: 1,953

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!

Complete thread:

UA Flag
 Admin contact
22,477 posts in 4,708 threads, 1,603 registered users;
12 visitors (0 registered, 12 guests [including 3 identified bots]).
Forum time: 22:36 CET (Europe/Vienna)

In these matters the only certainty is
that nothing is certain.    Pliny the Elder

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