Unnecessary regulation harming clinical research in the UK
17 October 2008
Increasing bureaucracy is the biggest single threat to clinical
research in the UK and urgent action needs to be taken, argue experts in
the British Medical Journal's online edition, bmj.com.
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 Professor Morris Brown of Addenbrookes Hospital, Cambridge, and
Professor Paul Stewart of the University of Birmingham.
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.
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