Published online 13 March 2009 | Nature | doi:10.1038/news.2009.163


European clinical trial rules under fire

European medical research strangled by red tape, scientists warn.

European legislation governing clinical trials is slowing research and may even be costing lives, leading scientists have warned.

Since it came into force five years ago, the European Clinical Trials Directive has drawn criticism from a number of researchers for its bureaucracy and complexity. As the European Commission considers changes to the legislation, those conducting trials now warn that the directive is making research at all levels less productive.

red tapeTangled up in red: clinical trials in Europe are complicated by bureaucracy, scientists claim.Punchstock

"If we prevent evidence from emerging that would save lives, I would interpret that as killing people," says Rory Collins, professor of medicine and epidemiology at the University of Oxford, UK.

The demands of the directive have also made the European Union (EU) less attractive to scientists wanting to run clinical trials, forcing them to conduct their research elsewhere, Collins adds. He claims that one senior official at the US Food and Drug Administration has labelled the directive as "Europe's gift to America".

The European Commission told Nature: "We don't support the claim that the regulation of clinical trials is 'killing people'. While there are a multitude of reasons why the conduct of clinical trials is increasingly challenging, the commission is aware that the adoption of high standards for clinical trials in the EU have rendered them, in some member states, more burdensome than before."

Clinical controversy

The European Clinical Trials Directive was designed to improve the standards of trials and harmonize procedures across EU member states, laying out best practice on seeking ethical approval, obtaining patient consent, responding to unexpected adverse reactions to drugs, and so on. Yet it has been hugely controversial since it was implemented in 2004 - not least because of the significant additional burden of paperwork that it requires.

The directive is applied in different ways from country to country. In the United Kingdom, for example, it covers only drug trials and multi-modal therapy trials. In France, however, it can also cover radiotherapy trials, surgery trials and cosmetic product trials (see Table 1).

It even affects those conducting early-stage physiological experiments, says Collins. "The definition of 'trial' is very broad," he says. "A lot of people have had to comply with regulation that goes across any use of a drug in humans."

The United Kingdom has been especially hard hit, according to results noted by Morris Brown, a pharmacologist at the University of Cambridge, UK, in one of the most recent papers to review the effects of the directive. The number of non-commercial trials in the country fell from around 600 carried out between 2000 and 2003 to fewer than 300 between 2004 and 2007, according to the Impact on Clinical Research of European Legislation (ICREL) project carried out by a consortium of European clinical and research centres1.

"At a time the available funding has probably never been more abundant," says Brown, "it takes all our time to go through the regulatory hoops."

However, Ingrid Klingmann, project coordinator for ICREL, says that while some countries, including the United Kingdom, have had fewer non-commercial trials, others, such as Italy, have had more. Klingmann, who is also the president of consultancy company Pharmaplex, adds that the directive has brought benefits in terms of harmonizing European regulations, although it has also increased costs.

Kent Woods, chief executive of the British government's Medicines and Healthcare Products Regulatory Agency (MHRA), says that the total number of clinical trials approved in the United Kingdom — including those managed by companies — has remained stable since the implementation of the directive.

But even a steady state is problematic, argues Richard Sullivan, a health policy expert and cancer researcher from King's College London. Noting that although funding for clinical trials has grown significantly, he estimates that the directive had doubled the cost of running non-commercial cancer clinical trials in the United Kingdom2.

The European Commission's reassessment of the directive is expected to report in 2010. 

  • References

    1. Brown, M. Br. J. Clin. Pharmacol.(2009) doi:10.111/1365-2125.208.03379
    2. Hearn, J., Sullivan, R. Eur. J. Cancer 43, 8–13 (2007).


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  • #60680

    Thank you for rocking the boat regarding this issue. As the CEO of the consultant company specialized in radio nuclear medicine, it is So obvious that even at the Ministry of health level, politician influence is unacceptable. i

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