Obstructive rules 'have put UK research in jeopardy'

UK clinical research will be 'seriously jeopardised' unless obstructive regulation is overhauled, a review has warned.

UK trials are being held back by 'burdensome legal frameworks' (Photograph: SPL)

Speaking at the launch of an investigation into current research regulation, experts said burdensome legal frameworks were stifling clinical trials, once the 'jewel in the crown' of UK medical research.

The study was commissioned in March by former health secretary Andy Burnham to assess how the process of clinical research could be streamlined.

Professor Sir Michael Rawlins, chairman of the Academy of Medical Sciences' group undertaking the study, said: 'There is widespread and increasing concern that the process of medical research is being jeopardised by a legal and regulatory framework that has become unnecessarily burdensome.'

Each study unnecessarily delayed or cancelled due to complex regulation may be another missed opportunity to develop new drugs and enhance patient care, he said.

The cost of drug trials has spiralled recently, with estimates suggesting it now costs 10 times as much to develop a new drug as 20 years ago.

A tenth of this increase is attributable to the cost of monitoring of trials by auditors, despite little evidence this is effective, the panel said.

In addition, UK regulation distorts the research being undertaken. The huge cost of trials tends to exclude non-industry research, such as trials of cheaper drugs, the panel warned.

Professor Rory Collins of Oxford University said the review was a 'fantastic opportunity to do things better' after 10 years in which there had been an increase in obstructive barriers to research.

'Britain led the world on (developing) statin drugs. I don't think that level of trials could have been done in the current environment,' he said.

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