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Dear all,
We have come across few cases of Malingering ie ., inducing vomiting by
volunteers in BE study, so that we will withdraw and pay him full
compensation.
As per the guidelines, data of the volunteers has to be deleted from
the analysis but on the ethical grounds since his data will be
deleted, he will be withdrawn from the study.
Finally during period II, we can be in trouble due to inadequate
sample size for conducting study due to these withdrawal.
So, to prevent such situation can be continue the volunteers in the
study, until the study completes.
Pls give your opinion and suggestions.
regards,
Dr.Sridhar
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Dear Dr.Sridhar
You might develop a volunteer information sheet (consent form) that
somehow makes it clear that if a volunteer has to be withdrawn
because of willful misconduct, that no compensation is to be
expected. This should discourage them.. And enter them on a 'black
list' to make sure they cannot ever participate again. And maybe
point that out during the screening session?
Regards,
Frieda Ebes, Kendle
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The following message was posted to: PharmPK
It's worth noting that the FDA bioequivalence guideline states that "
Data
from subjects who experience emesis during the course of a BE study for
immediate-release products should be deleted from statistical
analysis if
vomiting occurs at or before 2 times median Tmax." Volunteers who
leave it
too late to vomit, may, therefore, be retained in the study.
Regards,
Charlie
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