Missing samples [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2019-10-17 10:22  – Posting: # 20700
Views: 886

Hi ElMaestro,

» 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.

I see. Since the data are useless for the FDA’s reference-scaling maybe this was a trick-shot of the CRO to milk the sponsor.

» The alternative may be worse, depending on how you look at it: If a subject misses an ambulatory pk-sample […] should she/he then be considered completely out?

I like your examples! That’s an area of improvement which requires a good amount of intellectual horsepower. Not easy but the idea is to come up with rules specifying how many missings (and where) in the profile will likely lead to unreliable estimates of a given PK metric.

Cheers,
Helmut Schütz
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