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%.
The Clinical Trials Directive was transposed into UK law as the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031), taking effect on 1 May 2004.
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
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.