Potvin C in the EU [Two-Stage / GS Designs]

posted by ElMaestro  – Denmark, 2013-04-17 04:31 (3998 d 15:04 ago) – Posting: # 10425
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Hi Hötzi,

❝ new experiences from an ongoing MRP. Two studies (first one in two groups due to logistic reasons), Method C (!), all metrics in both studies passed in stage 1 (>80% power in the interim, no α-adjustment = 90% CIs).


Ahhh... MRP - a relic from the bygone ages when your grandad walked around in the snowy alps with bow and arrows looking for deer.

❝ Studies’ models in stage 1:

  1. Fixed:  sequence, period, treatment, group, group × treatment

    Random: subject(sequence)

  2. Fixed:  sequence, period, treatment

    Random: subject(sequence)

Accepted by Germany (RMS); no comments from Austria, Denmark, Sweden, and The Netherlands. Spain: “Statistical analysis should be GLM. Please justify. Please provide the NOL.”

❝ OK, I will repeat the analyses with all fixed effects (sigh; identical CIs…). ;-)


Anything to please the assessor. I have a feeling the assessor means LM but might not know what that really means since every LM in SAS is done via PROC GLM.
But honestly, group x treatment?? I'd rather not go down that road. I hope you do not make precedence.

❝ BTW, does anybody know what “NOL” means?


I am fairly sure it is either "No Objection Lertificate" or "Nixon's Obstructive Leprosy". I don't see what else it could possibly be.

Pass or fail!
ElMaestro

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