Top medical research organisations are calling on the European Union for urgent reforms to the way clinical trials are regulated across the continent.

Disproportionate regulation of European clinical trials is hampering research into potentially lifesaving treatments – without enhancing patient safety – according to sixteen organisations* including Cancer Research UK, the Academy of Medical Sciences, the British Heart Foundation, the Wellcome Trust and the European Science Foundation.

Their statement to the European Commission and Members of the European Parliament (MEPs) outlines how the European Clinical Trials Directive – which sets out the legal requirements for conducting clinical trials throughout the European Union – 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. This can cause unnecessary bureaucracy and makes it increasingly difficult for researchers to undertake multi-national trials.

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 percent increase in the time it takes researchers to get approval for their studies, and a 75 percent increase in administrative costs**.

Sir 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."

Betty McBride, Policy & Communications Director at the British Heart Foundation, 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."

Professor Sir John Bell FRS HonFREng PMedSci, President of the Academy of Medical Sciences, said: "Health research must be subject to proportionate regulation that both protects patients and facilitates globally-competitive research. 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 European Directive and stop a 'one size fits all' approach to trial regulation."

Professor Liselotte Højgaard, chair of the European Medical Research Councils (EMRC) of the European Science Foundation (ESF), 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. 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."

Professor Peter Johnson, Cancer Research UK's chief clinician, said: "Clinical trials are conducted to improve healthcare and that's why it's vital we strike the right balance between protecting patients and having regulations which are so bureaucratic that they prevent researchers advancing scientific knowledge and understanding. The huge expansion of paperwork has not helped to make research better or safer, just slower and more expensive. Simple steps, like reducing duplication and providing clearer more detailed rules can correct this without compromising standards.

"It's essential that European institutions and governments take action against over-regulation of clinical trials, to ensure that patients and the public can continue to reap the benefits from the world-class research taking place throughout the UK and Europe."

Source: CRUK