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Silke ☆ Germany, 2020-03-24 09:52 (1487 d 05:26 ago) Posting: # 21297 Views: 2,975 |
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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 |
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ElMaestro ★★★ Denmark, 2020-03-24 10:07 (1487 d 05:10 ago) @ Silke Posting: # 21298 Views: 2,308 |
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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   ).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 |
Ing. Helmut Schütz