I suspect the rationale for this has a lot in
common with the rationale for bureaucratic
paperwork-intense clinical aspects of clinical
research.
Less to do with Good Practice/quality/disaster
prevention than the need to drive research out of
the clinical setting into an arena where (to be
blunt) it can be cheated even more easily -
to contract research labs and contract clinical
research units, all under the thumb of industry
(both diagnostic and therapeutic).
The way in which the (widespread) cheating we are
seeing generally happens is completely different
from that which is monitored by GCP/Clinical Trial
regulations -- so we have a complete disconnect
between the problem and the solution. In fact the
solution is part of the problem, and deliberately
so.
Aubrey
==================
Blog: http://scientific-misconduct.blogspot.com/
==================
GC>
GC>
GC> Dear Colleagues
GC>
GC> Thanks to those who replied to my query.
GC> Problems only arise for those carrying out
GC> analytical work for clinical trials (which I
GC> suspect will be for the majority of UK NHS
GC> labs; clinical trials are popular with
GC> clinicians, and with NHS managers who see them
GC> as an income generation source). There is
GC> considerable overlap between CPA standards and
GC> GLP requirements. GLP certification (I
GC> believe originally set up at the behest of
GC> the FDA) or CPA accreditation, either or both,
GC> are required by the MHRA as part of the new
GC> regulations related to ICH GCP (clinical trial
GC> directive) across Europe for all labs
GC> providing analytical results for clinical
GC> trials. I believe GLP is an FDA requirement.
GC> However for analytical work, GLP requirements
GC> go some way beyond CPA requirements. Some
GC> different requirements are minor (a copy of
GC> lab reference ranges signed and dated by the
GC> HoD); some are intermediate (length of time
GC> that samples and data relating to it are
GC> stored); some have much more major
GC> implications (no change in method is allowed
GC> during the time of the clinical trial).
GC> Current guidance is unclear, but it is
GC> possible that failure to adhere to GLP
GC> requirements particularly for a trial the
GC> results of which which may need FDA approval
GC> may result in a clinical trial (which may
GC> cost many millions of pounds) being judged unacceptable.
GC>
GC> May I suggest that all labs undertaking
GC> clinical trial work make themselves aware of
GC> the requirements of GLP. I know that many
GC> labs undertake clinical trial work without
GC> even being aware of it: may I suggest that
GC> all as a matter of urgency inform their local
GC> clinicians and NHS managers that they are not
GC> necessarily compliant with GLP with regard to clinical trials.
GC>
GC> As a matter of sadness, I should state that
GC> the new requlations and demands regarding
GC> clinical trials will effectively mean that it
GC> is virtually impossible for NHS Pathology
GC> disciplines to comply with them, effectively
GC> ruling us out of any participation.
GC>
GC> On a pessimistic note
GC>
GC> Gordon Challand
GC>
GC>
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Regards
Aubrey Blumsohn
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