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RegisterRRT|RTR|TRR drop outs [Study Performance]
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.
» 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
Regards,
Detlew
Complete thread:
- volunteer exclusion Yura 2016-02-16 11:13
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- volunteer exclusion Dr_Dan 2016-02-16 14:12
- RRT|RTR|TRR? Helmut 2016-02-16 14:19
- RRT|RTR|TRR? Dr_Dan 2016-02-16 15:59
- RRT|RTR|TRR drop outsd_labes 2016-02-23 08:40
- volunteer exclusion Yura 2016-03-04 07:47
- RRT|RTR|TRR? Helmut 2016-02-16 14:19
- volunteer exclusion Dr_Dan 2016-02-16 14:12
Ing. Helmut Schütz