Author: Eva Pastor
Date: 05-15-10 15:18
Source: NaturalNews.com
URL: http://www.nature.com/news/2010/100514/full/news.2010.243.html
Date published: May 14th 2010
Published online 14 May 2010 | Nature | doi:10.1038/news.2010.243
UK doctors demand research reform
Cumbersome rules for clinical trials are driving research overseas, medical scientists warn.
Daniel Cressey
Medical researchers in the United Kingdom warned today that their work is being damaged by excessive regulation and an obsession with targets in the country's health service. Figures show that the number of trials put forward for ethical approval has dropped sharply in recent years.
At a meeting in London, about 50 leading clinical researchers unanimously backed a motion demanding that the National Health Service (NHS) be reformed to make conducting clinical trials easier. The motion warns that "vital industries [are] threatening to quit the NHS, with one of the main reasons cited being the slowness of the NHS system for clinical trials".
At the British Medical Association's (BMA's) annual Conference of Medical Academic Representatives on 14 May, all researchers present backed the motion in a show of hands.
"The number of research proposals going forward to the National Research Ethics [Service], is dropping year on year," Michael Rees, a cardiac specialist at Bangor University and the motion's proposer, told Nature before the conference. Feedback from researchers suggests it is getting more difficult to do research in the NHS, he added.
Clinical complaints
Data released in April by the National Research Ethics Service shows applications declining by more than a third between 2004–05 and 2009–10. All UK clinical trials must be approved by an ethics committee.
Rees, who co-chairs the BMA's Medical Academic Staff Committee, says the lack of a national system of research governance has left researchers struggling with a patchwork of local rules, hindering those running trials in multiple locations.
Another problem is clinical targets. Managers may be reluctant to back trials that require, for example, computed-tomography (CT) scans, says Rees, if this will make them less likely to hit government targets on CT scans for patients.
Without a central system of research governance and research targets for the NHS, "we will continue to decline as a country for biomedical research", says Rees.
Trial drain
Many UK researchers have previously raised fears about the country's ability to attract clinical trials, especially in the face of increasing competition from India and China.
Some say that British enforcement of European rules is too heavy-handed. One researcher at the meeting, who asked not to be named, said that a colleague in Germany had managed to conduct and write up the German part of a collaboration before the UK arm had been approved.
In January this year the UK Academy of Medical Sciences noted that the proportion of the world's clinical trials conducted in the United Kingdom fell from 6% in 2000 to 2% in 2006. It warned that forcing researchers to comply with a plethora of sometimes overlapping requirements from the EU Clinical Trials Directive, the European Medicines Agency, the Medicines and Healthcare Products Regulatory Agency, NHS ethics committees and several other bodies, is driving research overseas.
In March, the government asked the Academy of Medical Sciences to review these issues.
"There's a huge amount of hurdle-leaping to be done to get good patient benefit out at the end," says academy vice-president Ronald Laskey. "We are already seeing clinical trial activity moving overseas. That is an issue that needs to be addressed urgently."
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