protocol amendment that may trigger Group effect test [General Statistics]
❝ 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?
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 ).
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!
- protocol amendment that may trigger Group effect test Silke 2020-03-24 08:52 [General Statistics]
- protocol amendment that may trigger Group effect testElMaestro 2020-03-24 09:07