Clinical
News | September 27, 2011
The European Union’s Clinical Trials Directive has resulted in unnecessary
complexity and bureaucracy that are hampering the progress of medical research
by pushing up the time and costs needed to get clinical studies underway,
academic and industry stakeholders from the UK and Europe contend.
As European institutions
settle in after the summer recess, a mixed group of 16 commercial and
non-commercial organisations is keeping up the momentum for change in the
ongoing review of Directive 2001/20/EC by issuing a joint statement to the
European Commission and members of the European Parliament, outlining revisions
that could help to streamline the approvals process for clinical trials across
the EU.
The organisations want to see
clearer and more proportionate rules for clinical trials that maintain quality
and safety standards while reducing duplication, red tape and what Professor
Sir John Bell, president of the UK’s Academy of Medical Sciences, described as
“a ‘one size fits all’ approach to trial regulation”. A revised version of the
Clinical Trials Directive is expected to be published in mid-2012.
Academic and industry sponsors
have already responded individually and collectively to the European
Commission’s consultation programme on Directive 2001/20/EC. A recent
submission from the European office of the UK’s NHS Confederation suggested the
excessive burden of regulation imposed by the Directive had contributed to a
dramatic decline in the UK’s share of European and global clinical trials over
recent years.
In a similar vein, the
joint-statement group cites comparison data from the Drug Development Office of
Cancer Research UK, submitted between 2003 and 2007 to the Impact on Clinical
Research of European Legislation study. These data show that the average time
it takes to get approval for a clinical trial has increased by 65% while
associated administrative costs have risen by 75%.
Mixed bag
A number of the organisations
backing Revision of the EU Clinical Trials Directive. A joint statement from
non-commercial and commercial organisations are UK-based but the list also
includes representation from Germany, Europe and the international clinical
research sector.
The sponsors in full are:
Cancer Research UK; the European Organisation for Research and Treatment of
Cancer; the European Clinical Infrastructures Network; the European Science
Foundation (ESF); the International Brain Tumour Alliance; the Society for
Paediatric Oncology in Europe; the KKS Network of Clinical trials in Germany;
the Medical Research Council; the Association of the British Pharmaceutical
Industry; the Wellcome Trust; the Academy of Medical Sciences; Arthritis
Research UK; the Association of Medical Research Charities; the British Heart
Foundation; and the European Cancer Organisation.
Above and beyond
Above and beyond
A binding concern is that the
Clinical Trials Directive is being interpreted differently throughout Europe,
with evidence that researchers are going “above and beyond the requirements to
ensure they are compliant”, the medical research organisations note.
"It is absolutely right
that we work alongside other UK and EU research funders on the important issue
of revising the EU Clinical Trials Directive,” says Sir Mark Walport, director
of the UK-based Wellcome Trust.
“Increasing participation in
clinical trials is crucial to fully realising the benefits of medical research
for health and the economy in the UK,” he adds.
That goes for Europe too. “The
current system of regulation for clinical trials is unnecessarily complex and
bureaucratic and we believe this is holding back progress in medical research
across Europe,” comments Professor Liselotte Højgaard, chair of the ESF’s
European Medical Research Councils.
“It’s vital that the
recommendations put forward in this statement are taken forward to ensure that
Europe continues to be seen as an attractive destination for clinical
research,” Højgaard insists.