Researchers call for European clinical trial reform
pharmafile | September 28, 2011 | News story | Research and Development | Euorpe, clinical trials
Medical researchers are calling for regulatory red tape to be snipped away from the legal requirements around clinical trials in Europe.
A joint statement to the European Commission and MEPs by 16 organisations – including Cancer Research UK, the Wellcome Trust and British Heart Foundation (BHF) – says the rules around trials need to be stripped back to avoid stifling medical advances.
The main bugbear is the European Clinical Trials Directive 2001/20/EC (CTD), which they say is interpreted differently across Europe, making multi-national trials harder to conduct because of te unnecessary bureaucracy it adds.
The EC announced back in 2008 that it would assess the impact of the CTD, with a view to making proposals for change in the first half of 2012.
This week’s joint statement from the 16 groups says legislation should be revised in three ways: by streamlining authorisation processes, adopting a ‘proportionate’ approach to regulation and by providing clearer guidance.
“Proportionate clinical trials regulation will promote medical research in Europe, protecting participants without the hindrance of complex bureaucracy,” says Sir Mark Walport, director of the Wellcome Trust.
What the statement calls a “one size fits all” approach means trials of well-understood drugs are regulated in exactly the same way as trials of completely new drugs, where the risks are unknown.
The statement also says the CTD has led to a 65% rise in the time it takes researchers to get approval for their studies, and a 75% increase in administrative costs.
It details case studies (see below) in which the CTD has led to cost hikes, increased administration in some countries but not others or, in one case, led to a trial simply not taking place at all in the UK.
“Increasing participation in clinical trials is crucial to fully realising the benefits of medical research for health and the economy in the UK,” Sir Mark adds.
His words are echoed by the BHF, which says researchers find it more and more difficult to carry out clinical research in the UK due to “over burdensome” regulation.
“It may prove a disincentive to them continuing a research career,” warns BHF policy and communications director Betty McBride.
“The Commission and Parliament need to seize this opportunity to reform the Directive, and ensure clinical trials are conducted safely and to high standards without overwhelming researchers with red tape.”
Case studies: the CTD in practice
In 2004, Arthritis Research UK funded a study looking at the effect of Vitamin D on older people with knee osteoarthritis. But because the product was classed as an investigational medicinal product (IMP) under the CTD, researchers had to pay £70,000 to have it ‘repacked’ – despite it being available across the EU from online health stores.
The BHF says the ARCH trial (Aortic Arch Related Cerebral Hazard), already running in France, was found under the UK interpretation of the Directive to require approval from the MHRA – yet no equivalent approval had been required by French authorities. Therefore 100 patients who would have been recruited in the UK did not participate.
Cancer Research UK says the EuroNet-PHL-C1 trial for children and young people under 18 years old, comparing different ways of treating Hodgkin’s lymphoma to help lower the risk of long-term side effects, highlighted a lack of common understanding in the definition of IMPs under the CTD: the number of IMPs included on the Clinical Trials Authorisation in different member states varies from as many as 14 to as few as two.
Adam Hill
Related Content
Vesper Bio reports positive topline results for dementia candidate
Vesper Bio, a clinical-stage biotech developing novel oral therapies for neurodegenerative and neuropsychiatric disorders, has …
Von Willebrand disease – increasing awareness and access to vital care
Pharmafile talks to Anthea Cherednichenko, Vice President Franchise Head Haematology and Transplant at Takeda about …
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
