Unnecessary Regulation Harming Clinical Research In The UK, Say Experts

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 17 Oct 2008 - 5:00 PDT

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Increasing bureaucracy is the biggest single threat to clinical research in the UK and urgent action needs to be taken, argue experts on bmj.com today.

European legislation introduced in 2001 was intended to simplify and harmonise the regulation of trials across the European Union. But it has led to long delays in approval, is "poorly coordinated, lacks inconsistency at all levels, and at times is completely illogical", write Professors Morris Brown and Paul Stewart.

Because of the increasingly complicated and time-consuming approval process, the UK has fallen from being one of the most attractive places for the pharmaceutical industry to undertake clinical trials to one of the least attractive, warn the authors.

Main concerns of the authors include the lengthy application process - paperwork can take up to 40 hours to complete, the inconsistencies and delays in the review process, and the lack of clarity about what requires ethical approval.

According to the authors, another key problem is the ineffectiveness of the Medicines and Healthcare Products Regulatory Agency (MHRA) approval process - the application is difficult to complete, cannot be submitted online and is sometimes lost by the MHRA.

The MHRA was set up to investigate new medicinal products, but its extended responsibility to approve all clinical trials in the UK has been counterproductive, say the authors.

"The process adds long delay for no perceived benefit..No improvement in patient safety has been demonstrated as a consequence of the extra tier of bureaucracy for such studies", say the authors, "On the contrary, the MHRA failed to prevent the TeGenero disaster at Northwick Park - or acknowledge its failure".

So what needs to be done?

The recently formed National Institute of Health Research (NIHR) has already begun a "bureaucracy busting" mission, say the authors, but they outline a number of recommendations to reduce research bureaucracy.

For example, they suggest a single and simple web based submission form for all research studies, rather than a different form for every funding and governance organisation. In addition, they suggest a national and consistent ethical review process to replace the current "postcode lottery", and an automatic grading of applications which would make patient safety "self evident".

They conclude by calling for the MHRA to concentrate on its primary responsibility, and ensure that medicines work and are safe.

"Regulation - the real threat to clinical research"
Paul M Stewart, Anna Stears, Jeremy W Tomlinson, Morris J Brown
BMJ 2008;337:a1732 doi:10.1136/bmj.a1732
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British Medical Journal
http://www.bmj.com