Emesis during BE study [Study Per­for­mance]

posted by Dr.Sridhar – 2007-10-11 18:40 (6478 d 09:46 ago) – Posting: # 1174
Views: 6,300

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volunteers has to be deleted from the analysis but on the ethical grounds since his data will be deleted, he will be withdrawn from the study.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

Complete thread:

UA Flag
Activity
 Admin contact
23,427 posts in 4,929 threads, 1,679 registered users;
30 visitors (0 registered, 30 guests [including 11 identified bots]).
Forum time: 04:26 CEST (Europe/Vienna)

No matter what side of the argument you are on,
you always find people on your side
that you wish were on the other.    Thomas Berger

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5