RRT|RTR|TRR drop outs [Study Per­for­mance]

posted by d_labes  – Berlin, Germany, 2016-02-23 08:40  – Posting: # 16019
Views: 4,322

Dear Helmut,

» the forum’s jury is still out and we are awaiting its verdict how to deal with the partial replicate design (RRT | RTR | TRR). If a subject drops out after the second period in the sequence RRT
» I (!) would still include him / her in the estimation of CVwR. More data = better estimate.
emphasis by me

Me too. The SAS code of the FDA progesterone guidance forces this also: no missing in the calculation of the intra-subject contrast R-R.

But this requires that drop-outs are not considered as protocol deviation / violation in the study protocol.

Regards,

Detlew

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