I think it depends on what you mean by "clinical
trial".
The MHRA (at least in theory) is concerned with
the integrity and honesty of trials where those
trials are carried out specifically for purposes
of licencing or where they are intended to
provide data to the MHRA. They have stated
explicitly that they have no remit in terms of
fraud or clinical trial problems in any other
respect (GSK and seroxat studies providing the
most striking example, but there are many others).
The MHRA is entirely unconcerned about fraud in
the scientific literature involving drugs where
unrelated to the above. Obviously many clinical
trials are post-licensing or are not intended for
regulatory submission. It may be that these should
adhere to certain standards, but it is not clear
why the MHRA should have a role.
Aubrey
DB> May I canvass the opinions of mailbase users
DB> concerning the guidance issued
DB> by the MHRA "......on the maintenance of
DB> regulatory compliance in laboratories
DB> that perform the analysis or evaluation of
DB> clinical trial samples."
DB> I have the impression that this addresses the
DB> proper running of laboratories
DB> where clinical research is ongoing but not to
DB> diagnostic labs where routine
DB> testing is an adjunct to the apraisal of
DB> patients participating in clinical trials. I
DB> have sought guidance on this question in the
DB> past and was assured that CPA
DB> accredited labs were demonstrably providing
DB> services to the appropriate
DB> national quality standard. What do you think?
DB> Regards,
DB> David
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Regards
Aubrey Blumsohn
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Please note, archived messages are public and can be viewed
via the internet. Views expressed are those of the individual and
they are responsible for all message content.
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