Missing periods in replicate designs [RSABE / ABEL]

posted by ElMaestro  – Denmark, 2019-10-16 15:10 (1037 d 06:27 ago) – Posting: # 20693
Views: 8,263

Hi Hötzi,

» I would say:
  • If a subject does not show up or withdraws consent before the first dose, that’s the end of the story.
    »
  • If a subject drops out in later periods, end of the story as well. Why did they come back?
Did you see cases like this? And if yes, do you know why?

Not a definitive answer, but at some CROs they have SOPs in place to the effect of allowing subjects to come back after they have skipped a period , or fractions of one. This, I think, relates originally to FDA's data driven policies. A subject can walkout on her/his own initiative without even stating a reason, that's how GCP works. There is no clause saying she/he can't come back.
I know, this is messy, but that's the way it is in some clinics.

The alternative may be worse, depending on how you look at it: If a subject misses an ambulatory pk-sample ("I forgot", "I sat stuck in a traffic jam", "My parrot suffered an anxiety attack", "Don't you fucking ask me what I did yesterday, it's none of your business", "I had to watch Conchita Wurst win the Grand Prix" etc.) should she/he then be considered completely out?

Pass or fail!
ElMaestro

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