Published 13 March 2009, doi:10.1136/bmj.b1052
Cite this as: BMJ 2009;338:b1052

News

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

Anne Gulland

1 London

The first 150 words of the full text of this article appear below.

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 . . . [Full text of this article]


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Is this limited to the UK?
Paolo Tomasi
bmj.com, 18 Mar 2009 [Full text]
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