Number of global clinical trials done in UK fell by two thirds after EU directive

A leading clinician has warned that patients are dying because a European Union directive that was intended to streamline the process of clinical trials has had the opposite effect.

Rory Collins, professor of epidemiology and medicine at Oxford University, told a briefing organised by the Science Media Centre on the threat to clinical trials that the “hugely increased bureaucratic burden” had made it much more difficult to investigate new treatments.

“It’s killing people. I believe that’s a fact,” he said. “People are dying unnecessarily because the way in which the regulation and bureaucracy is working has prevented us getting the evidence we need.”

The European Union Clinical Trials Directive came into effect in 2004 with the intention of harmonising clinical trials throughout Europe, lessening the bureaucratic burden, and improving the safety of patients. However, the opposite has happened, said John Bell, president of the Academy of Medical Sciences. He said that the directive had been applied differently in different EU countries and that the bureaucratic burden has increased. “It is not clear what it has done to patient safety,” he added. Governance of clinical research in the NHS has added another layer of bureaucracy in the United Kingdom, he added.

Professor Collins said that multinational, large scale trials were at particular risk because of the spiralling costs of carrying out research. A third of the cost of a large scale trial now goes on site visits to monitor the trial. “Empirical evidence shows that site monitoring is not an effective way of picking up problems,” he said.

He said that a trial led by researchers at the London School of Hygiene and Tropical Medicine investigating the treatment of patients with head injuries had been able to recruit only 100 patients because of rules introduced under the directive governing patient consent.

According to figures from the Medicines and Healthcare Products Regulatory Agency 1085 clinical trials were carried out in the UK in 2005 compared with 1252 in 2008.

Kent Wood, chief executive of the agency, said, “The number of trials is steady but not rising. Considering the investment that has gone into clinical trial infrastructure that is disappointing.”

The Clinical Trial Directive will be reviewed next year and Professor Woods urged the clinical research community to lobby politicians. Researchers are calling for an approach based on risk, with research into refining existing treatments given a lighter regulatory touch than investigations into new drugs.

Professor Collins used the example of a trial looking at the use of aspirin among patients with diabetes, where every single pack of aspirin used in the trial had to be labelled with a patient identifier, a hugely costly exercise.

Professor Bell said that the UK’s “spectacular” record in the field of clinical trials was in danger of being lost. Figures from the Centre for Medicines Research showed that in 2002 6% of global clinical trials took place in the UK, compared with 2% in 2007, three years after the EU directive took effect.