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RegisterDose subjects but not using them [Two-Stage / GS Designs]
Dear Kotu,
sounds to me in contrast to our Capt'n like something similar to 'spare' subjects.
The EMA guidance states in this respect:
"The data from all treated subjects should be treated equally. It is not acceptable to have a protocol which specifies that ‘spare’ subjects will be included in the analysis only if needed as replacements for other subjects who have been excluded. It should be planned that all treated subjects should be included in the analysis, even if there are no drop-outs."
Moreover it is IMHO highly unethical to expose subjects to the API and taking blood samples from them for nothing (not to use their data).
sounds to me in contrast to our Capt'n like something similar to 'spare' subjects.
The EMA guidance states in this respect:
"The data from all treated subjects should be treated equally. It is not acceptable to have a protocol which specifies that ‘spare’ subjects will be included in the analysis only if needed as replacements for other subjects who have been excluded. It should be planned that all treated subjects should be included in the analysis, even if there are no drop-outs."
Moreover it is IMHO highly unethical to expose subjects to the API and taking blood samples from them for nothing (not to use their data).
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- BA/BE Studies for Early Termination balakotu 2015-09-22 13:05
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BA/BE Studies for Early Termination ElMaestro 2015-09-22 13:35
- Dose subjects but not using themd_labes 2015-09-22 13:49
- IMHO, that’s a TSD… Helmut 2015-09-22 13:58
Ing. Helmut Schütz