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Clinical research 'suffocating under bureaucracy'

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Red tape is stifling British clinical research, a new report has claimed.

Action is needed to clear away bureaucracy and speed up the transfer of new discoveries from lab bench to hospital bed, said the Academy of Medical Sciences.

Its central recommendation is the creation of a new independent health research agency to regulate and supervise medical research. The agency would work with regulatory bodies around the UK to develop an integrated approvals system.

Sir Michael Rawlins, who chaired the working group which prepared the report, said: “A fertile research environment is vital for the health and wealth of the UK. The current system of regulation is making it increasingly difficult to initiate health research in the UK and is preventing patients from participating in studies.

“This is ultimately denying patients early access to new drugs and hindering improvements to public health for the wider society.

“We have found unequivocal evidence that health research in this country is being jeopardised by a regulatory and governance framework that has become unnecessarily complex and burdensome. Further, we received no evidence that this increased regulatory and governance burden has led to enhanced safeguards for participants in research.

“The changes we propose will streamline and improve the process to create a better environment for research, while protecting the interests of patients and the public.”

The report calls on the Department of Health to set up a national research governance service for England within the new agency. This would assume responsibility for safety checks currently duplicated by NHS trusts participating in patient trials.

The aim is to speed up approval of NHS-based research studies.

Health secretary Andrew Lansley said the government welcomed the report and would consider how to implement its recommendations.

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