Silke
☆    

Germany,
2020-03-24 07:52
(253 d 14:11 ago)

Posting: # 21297
Views: 1,762
 

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

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
ElMaestro
★★★

Belgium?,
2020-03-24 08:07
(253 d 13:56 ago)

@ Silke
Posting: # 21298
Views: 1,342
 

 protocol amendment that may trigger Group effect test

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

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.
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