I would like to know whether subjects who withdrew early in a trial or were lost to follow up should
be excluded from the PP population.
My thoughts : There was nothing specific in the trial protocol regarding withdrawals being excluded,
but I am aware that withdrawal may not have been a random event and may have been the result of
an unknown cause that was not accounted for in the design of the study. Thus bias may be
introduced if these subjects are included in the Per Protocol population.
In the study all subjects were treated by injection at baseline and there was no subsequent re
treatment for any subject.
Should I include these withdrawals in the Per Protocol population or not ? If anyone has a link to any
non study specific general inclusion / exclusion criteria for the per protocol population I would be
grateful for the link.
Many thanks
Jon
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