By Martin Banks - 26th September 2011
The commission and parliament need to seize this opportunity to reform the directive
Betty McBride
Top medical research organisations have called on the EU to carry out urgent reforms to the way clinical trials are regulated across the continent.
They claim that "disproportionate" regulation of European clinical trials is hampering research into potentially lifesaving treatments – without enhancing patient safety.
The 16 organisations include Cancer Research UK, the Academy of Medical Sciences, the British Heart Foundation, the Wellcome Trust and the European Science Foundation.
Their appeal to the European commission and MEPs outlines how the European clinical trials directive – which sets out the legal requirements for conducting clinical trials throughout the EU – should be revised to "help streamline the approval process" for clinical trials.
The directive is interpreted differently throughout Europe with evidence that those undertaking trials go above and beyond the requirements to ensure they are compliant.
The alliance says this can cause unnecessary bureaucracy and makes it increasingly difficult for researchers to undertake multi-national trials.
They say the knock-on effect of this has been a significant increase in the average cost and time it takes for trials to get up and running, with an estimated 65 per cent increase in the time it takes researchers to get approval for their studies, and a 75 per cent increase in administrative costs.
Mark Walport, director of the Wellcome Trust, said, "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.
"Proportionate clinical trials regulation will promote medical research in Europe, protecting participants without the hindrance of complex bureaucracy.
"Increasing participation in clinical trials is crucial to fully realising the benefits of medical research for health and the economy in the UK."
Further comment came from Betty McBride, of the British Heart Foundation, who said, "Our researchers have told us that it's becoming more and more difficult to carry out clinical research in the UK due to the over burdensome regulation and that it may prove a disincentive to them continuing a research career.
"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."
John Bell, president of the Academy of Medical Sciences, agreed, saying that health research must be subject to "proportionate" regulation that both protects patients and facilitates globally-competitive research.
Bell said, "The current regulation of clinical trials in Europe is causing unnecessary delays and complexity which is stifling medical advances, without additional benefits to patient safety. We must make changes to clarify the scope of the current directive and stop a 'one size fits all' approach to trial regulation."
His comments are echoed by Liselotte Højgaard, chair of the European Medical Research Councils (EMRC) of the European Science Foundation (ESF).
She said, "A major objective of the EMRC is to facilitate investigator-driven clinical trials therefore we fully support this statement.
"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."
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