E-drug: Risks for patients in clinical trials
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Dear E-Drug readers,
Today's entry on the Social Audit website may be of some interest.
The source is excellent, and the data impressive: they point to
significant risks for patients involved in clinical trials - apart from
raising big questions about the reliability of trials' results. See:
http://www.socialaudit.org.uk/5100what.htm
Abstract of this item as follows: "Seminal new evidence points
to systematic and sometimes fundamental inadequacies in the conduct of
clinical trials. In this letter to the Secretary of State
for Health, Social Audit asks what the MCA/CSM know about
standards of compliance with Good Clinical Practice (GCP) guidelines - and
what they propose to do to reduce risks for
patients and to eliminate sloppy research practice in
clinical trials conducted in the UK and elsewhere. This letter
was prompted by the findings of some 800 GCP audits
conducted by a relatively small commercial consultancy -
but with much more experience in this field than
the MCA. Patients considering involvement in clinical trials
should be aware of the conclusions of one of the directors of
this consultancy, Wendy Bohaychuk PhD:
"Our database of GCP compliance assessment basically shows
that new GCP guidelines and regulations have not yet improved
the situation for patients over the last few years and frankly, after
10 years of detailed auditing, I would never go into a clinical study myself
and I would certainly try to discourage anyone in my family
from doing so."
This issue is also the subject of a feature and editorial in The Guardian,
27 July 1999.
I hope this is of interest and use
Charles Medawar
Social Audit Ltd
PO Box 111
London NW1 8XG
Telephone/FAX: +44 (0)171 586 7771
http://www.socialaudit.org.uk
Email: charle@socialaudit.org.uk
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