Dear Colleagues,
As you will probably have heard by now, many clinical investigators
believe that the new European Directive on Clinical Trials threatens the
future of independent and academic clinical research throughout the E.U.
While attempts are being made to encourage individual member states to adopt
"flexible" interpretations of the guidelines, many believe that the
fundamentals of the Directive contain within them insurmountable barriers
for the independent clinical trials process itself. As such, we believe that
the best outcome is that the Directive, which was probably conceived in good
faith, but with inadequate consultation and consideration of its
consequences, be repealed, or, substantially amended. We have had an expert
opinion that such repeal is possible, but will present a formidable
challenge.
In only the first two weeks of its existence the "Save European
Clinical Research Campaign" has rapidly grown, and is already a
wide-ranging, inclusive, continent-wide coalition of clinical investigators
and advocates. Listed below are the signatories who have singed on to the
enclosed statement, which we will soon disseminate as an
advertisement/letter to the editor/letter to MEPS and commissioners. Please
note the growing involvement of the patient advocacy community.
The MEPs and Commissioners must be made to understand that their
action will not only hinder potentially life-saving research, but will put
Europe at a competitive disadvantage vis-à-vis North America. It will cost
lives.
The action plan is to get as many signatories as possible, and to
lobby the MEPs directly and intensively. We need your help. Please read the
petition at the website www.SaveEuropeanResearch.org
<http://www.SaveEuropeanResearch.org> and if you can, please sign it
electronically. Let us know if you are speaking on your own behalf, or
representing your organisation.
Over the next several days, we will begin the actual lobbying effort,
with an email including a list of early signatories to every MEP and
Commissioner. As others join the campaign their names will also be forwarded
to the recipients.
The "Save European Clinical Research Campaign" is being co-ordinated
by ICORG (the Irish Clinical Oncology Research Group) (
[log in to unmask] <mailto:[log in to unmask]> ) and the Breast
International Group, but is an open campaign on behalf of many
organizations. We would welcome your affiliation. Please contact us via
ICORG.
Please feel free to forward this email to your Colleagues/Members.
-----------------------------------------
Dr Brian Moulton
Chief Executive Officer
Irish Clinical Oncology Research Group
Member of EU steering committee on Cancer Research Management (ECRM)
120 Pembroke Road
Ballsbridge
Dublin 4
www.icorg.ie <http://www.icorg.ie>
phone: +353 1 6677211
_______________________________________________________________________
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_______________________________________________________________________
Olive Goddard
Centre and Editorial Manager
Centre for Evidence-Based Medicine
Room 4
Oxford University Department of Psychiatry
Warneford Hospital, Headington
Oxford, OX3 7JX
.....................................................................
Tel: +44 (0)1865 226485 email: [log in to unmask]
Fax: +44 (0)1865 793101 web: www.cebm.net
Mobile: 0773 484 2403 web: www.cebmh.com
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