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UK Seeks 'Rapid' Review of Framework for Medical Research

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb) — The UK government has requested the Academy of Medical Sciences conduct a "rapid" independent review of how medical research is regulated and governed in the kingdom, with an eye to eliminating roadblocks that have pushed clinical trials and other activity overseas.

"The UK has historically supported vibrant, research-intensive medical science industries and world-renowned academic medical science centres, but a cumbersome regulatory environment is driving this work abroad," Sir John Bell, president of the Academy of Medical Sciences, said in a statement released by the academy. "Ultimately this is harming patients by denying them access to new medicines."

Bell added, "Medical research must be subject to robust regulation that both protects patients and facilitates globally competitive research."

The academy is reviewing the medical framework through a working group chaired by Sir Michael Rawlins, and consisting of "senior figures drawn from across the medical sectors and beyond," according to a statement from the UK's Department for Business, Innovation and Skills, which announced the review on March 26.

The announcement came more than two months after the academy on Jan. 11 called for the review in a report, Reaping the Rewards: a Vision for UK Medical Science. The report noted that between 2000 and 2006, the proportion of the world's clinical trials conducted in the UK fell from 6 percent to 2 percent, with much of that activity going to other European nations.

"The UK's competitors, including the USA, China, Canada, and Singapore, have begun to realise the huge potential of medical research to both their economies and public services, and are implementing robust policies to grow this crucial sector. Decisive action is needed now to attract and anchor increasingly mobile medical researchers and life science industries in the UK," the report concluded.

The BIS statement said a specific focus of reviewers will be the challenges that have encouraged many academic research institutions and commercial drug developers to pursue clinical trials outside the UK, whether elsewhere in Europe, in the US, or in lower-cost developing nations.

Those challenges include the UK's low patient recruitment rates, complex health bureaucracy, and pace of new drug reviews — problems discussed in the January report.

"It is becoming increasingly clear that medical research is getting tied up in red tape. For research to flourish and provide the huge benefit it can give to the health and wealth of the country, it needs freedom from unnecessary bureaucracy and interference," UK Health Secretary Andy Burnham said in the BIS statement.

According to the Department of Health, the UK saw 470 mid-stage, late-stage and post-approval (Phase II through IV) trials during 2009, down 35 percent from 728 in 2008.

Within Europe, according to data published last year by Clinical Trial Magnifier, the UK ranked number five in sponsored Phase II and III trial sites as of 2006 with 3,592; Germany topped the list with 9,420 sites.

Hoping to reverse that trend, the UK's Medical Research Council last year spent £16
million ($24.4 million) to establish a national network of seven hubs designed to develop new methods, and improve existing ones, for designing, conducting, analyzing, and reporting clinical trials.

And in recent years, the health department has worked with the Association of the British Pharmaceutical Industry, the BioIndustry Association, and the Association for British Healthcare Industries to revise the 2003 model clinical trial agreements for use with biotech and pharmaceutical companies, and create new model agreements governing trials conducted by contract research organizations, and involving patients at National Health Service hospitals.

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