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European red tape holds back UK research, say academics

BMJ 2009; 338 doi: https://doi.org/10.1136/bmj.b223 (Published 20 January 2009) Cite this as: BMJ 2009;338:b223
  1. Lynn Eaton
  1. 1London

    Clinical academics are becoming increasingly concerned at the growing number of hurdles that must be overcome to get funding for medical research in the United Kingdom.

    They argue in a recent letter to the Times that UK research is being jeopardised by the plethora of checks and counterchecks, which can delay the start of a trial by as much as two years (www.timesonline.co.uk, 14 Jan, “UK research trials are on verge of extinction”).

    More than 100 academics signed the letter, originally drawn up by Morris Brown, chairman of clinical pharmacology at Cambridge University, and also signed by George Griffin, chairman of the Association of Clinical Professors of Medicine. Other signatories include Ian Gilmore, president of the Royal College of Physicians.

    “European directives introduced to ‘harmonise’ clinical research have led, in the UK, to an explosion of agencies that add months or even years to the simplest and safest pieces of research, and millions of pounds to the cost,” they write.

    The signatories claim that the number of patients recruited to trials in the UK has dropped to a third of previous levels; that the number of studies for which approval is sought has dropped by 30%; and that the number of non-commercial trials for which approval is sought has halved.

    But the letter has baffled many researchers, who say it is out of touch with current arrangements for research applications.

    “This would have been much more useful two years’ ago,” said Richard Tiner, medical director at the Association of the British Pharmaceutical Industry. “Most of the problems they allude to have been sorted out or are in the process of being sorted out.”

    Kent Woods, chief executive of the Medicines and Healthcare Products Regulatory Agency (MHRA) refutes the academics’ claim that fewer trials are approved in the UK, which continue to be about 1200 a year.

    He and Janet Wisely, director the National Research Ethics Service, say that the UK has the most non-commercial trials in the European Union but that clinical academics have had difficulty “negotiating the changed environment” of NHS research applications in recent years.

    But they and Dr Tiner say that recent changes should improve the situation. NHS approval of trials, the final stage in the application, will be streamlined from April 2009, for instance. The National Institute for Health Research will run a new coordinated system for gaining NHS Permission, which will avoid NHS trusts having to do their own check on the research ethics. Instead they can check whether approval has been given by the MRHA or ethics committee, and follow that decision.

    Dr Tiner adds that new 60 day time limits on MRHA and ethics committee approval, which can be done concurrently, have speeded up the process considerably.

    But Professor Griffin stands by his letter. “It came from sheer exasperation,” he said. “We felt something needed to be done. While we look forward to any new arrangements, they have not had any effect yet.”

    Notes

    Cite this as: BMJ 2009;338:b223

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