Missing periods in replicate designs [RSABE / ABEL]

posted by d_labes  – Berlin, Germany, 2019-10-17 17:22  – Posting: # 20701
Views: 925

Dear Helmut!

» 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. ...
» Did you see cases like this? And if yes, do you know why?

Yes, I saw such cases in times I was active.
F.i. a subject refuses consent after the 2nd period but came back due to invention of the investigator (by phone) for the 4th period (arguments: "you will not get payed if you refuse, only if you come back" or "Please, please be so kind to continue because otherwise we have not the scientific success we expected" and so on. See ElMaestros post for other examples.)

What to do with such data? DUNO exactly.
You yourself have described what to do for EMA ABEL or FDA RSABE.
Any case left?

Regards,

Detlew

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