Medical research organisations urge reform of clinical trials

Sixteen top medical research organisations, including Cancer Research UK and the Medical Research Council (MRC), are calling today on the European Union for urgent reforms to the way clinical trials are regulated across the continent.

They argue that the disproportionate regulation of European clinical trials is impeding research into potentially lifesaving treatments without improving patient safety.

Betty McBride, policy & communications director at the British Heart Foundation, accuses the current laws of “over-burdensome regulation”, and is applying for changes to the European Clinical Trials Directive, to ensure safety “without overwhelming researchers with red tape”.

The organisations’ statement to the European Commission and Members of the European Parliament (MEPs) outlines how the 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.

This could also lead to increased involvement in trials. Sir Mark Walport, director of the Wellcome Trust, argues that high levels of participation are “crucial to fully realising the benefits of medical research for health and the economy in the UK”.

The statement charges the directive with causing unnecessary bureaucracy for those undertaking trials, as they must go above and beyond the requirements to ensure they are compliant. It argues that this makes it increasingly difficult for researchers to undertake multi-national trials as well as significantly increasing the average cost and time it takes for trials to begin.

The medical research organisations calling for the reforms reiterate the importance of the changes in order to ensure that Europe maintains its reputation for advances in clinical research. Professor Sir John Bell, president of the Academy of Medical Sciences, stresses the importance of a new directive which “facilitates globally-competitive research”, claiming that the current directive “is stifling medical advances” in Europe.

Cancer Research UK’s chief clinician Professor Peter Johnson said: “Simple steps, like reducing duplication and providing clearer, more detailed rules, can correct this without compromising standards.”