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

posted by Silke – Germany, 2020-03-24 08:52 (134 d 23:01 ago) – Posting: # 21297
Views: 1,485

Dear Helmut,

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

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?

Thanks :-)

kind regards,
Silke

Complete thread:

Activity
 Admin contact
20,969 posts in 4,374 threads, 1,461 registered users;
online 17 (1 registered, 16 guests [including 10 identified bots]).
Forum time: Thursday 08:53 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