Missing periods in replicate designs [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2019-10-16 13:14  – Posting: # 20690
Views: 954

Dear all,

sometimes I see reports with a strange pattern of missing periods, e.g., subjects without the 1st period, subjects with only the 1st and the 4th, etc. Since I have only the statistical part of the report, I have no clue what was going on.
For the FDA’s RSABE only subjects with complete data (all periods) are used. But this is not the case for the EMA’s ABEL (all subjects with at least one T and R treatment for the calculation of the CI, all subjects with two R treatments for the calculation of CVwR).

I would say:Did you see cases like this? And if yes, do you know why?
I saw even cases where a subject in sequence TRTR had data only of periods 1 & 3. Useless.
Another case: 44 subjects had two administrations of T and R. However, 15 had two administrations of T and 39 two administrations of R. Chance – or what?

Cheers,
Helmut Schütz
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