A Lancet Editorial today backs the recommendations of a working group from the Academy of Medical Sciences led by Sir Mike Rawlins—Chairman of the UK National Institute of Health and Clinical Excellence (NICE)—recommending that red tape be slashed and process streamlined to transform UK health research from the bureaucratic nightmare it has become. The working group recommends the creation of a single health research agency to achieve this aim
In a Comment published together with the report and the Editorial, Sir Mike says that "UK clinical research has become unnecessarily stifled by incremental bureaucratic arrangements over the past 10 years". He adds: "The European Clinical Trials Directive has—as predicted 7 years ago—been a disaster. Although introduced with the best of intentions, the Directive has placed unnecessary and unreasonable burdens on commercial and publicly funded trials."
Sir Mike also criticises the approach taken by the Medicine and Healthcare products Regulatory Agency (MHRA), charged with overseeing trials, by saying that researchers reported the approach taken during inspections was "adversarial" and "concerned with box-ticking minutiae" rather than taking a proportionate approach.
Also criticised are the multitude of approval processes needed for a trial to commence, often involving several UK National Health Service (NHS) trusts and multiple ethics bodies. And Sir Mike adds that, while there are shining examples of NHS-led research, "too many [NHS trusts] regard it as either an unnecessary distraction, risky, or—worst of all—an income stream." Trust boards must take greater notice of and pride in research.
This new Health Research Agency proposed by the working group should have two roles: to streamline the current disparate arrangements for ethical approval and to provide a new National Research Governance Service. The agency would house not only the National Research Ethics Service, but all also take responsibility for specialist research ethics approvals.
Sir Mike recommends that The European Clinical Trials Directive needs a radical overhaul with repeal of the most egregious provisions, as well as amendments to its other over-restrictive requirements. The MHRA should also improve its engagement with NHS Trusts and the research community—working to address current perceptions of the combative approach taken by the inspectorate when monitoring sites.
He says: "We urge the clinical research community, as a whole, to make greater and more sustained efforts to promote and explain its contributions to the public. Evidence suggests that the public generally indeed support biomedical research; but those involved in clinical research could do much more to explain what they are doing, why they are doing it, and the benefits that their work brings to promoting and sustaining the public's health."
He concludes: "A new era for UK clinical research? We believe the Academy's proposals will increase and enhance UK clinical research without, in any way, reducing the protection that patients and the public are entitled to expect."
The linked Lancet Editorial adds: "The Rawlins review is an important piece of work that incorporates the views of many hundreds of stakeholders across industry, academia, the NHS, and medical research charities. The focus on streamlining and pragmatism is welcome. But, even assuming that the proposals can be implemented in a timely manner, can they deliver on the expectation to protect UK health research from further erosion? The answer is contingent on the UK having a strong NHS and a strong university sector, both of which are in substantial doubt. The NHS is about to undergo one of the biggest upheavals it has seen for decades, as the 151 Primary Care Trusts head for abolition and general practitioners assume responsibility for their own budgets as part of multipractice 'consortia;... The university sector is also facing chaos as cuts to teaching budgets force institutions to consider redundancies and closures."
It concludes: "The Rawlins review sets out a comprehensive strategy for improving clinical research governance in the UK. We urge the government to accept the proposals in full. But the performance of UK health research will depend on more than these. Without a strong NHS and adequately funded university sector, the UK will not be able to stem the decline in clinical trial research performance. Here we foresee new reasons to be anxious."
Sir Michael Rawlins, Chairman, NICE. T) +44 (0) 773 980 9006 E) michael.rawlins@nice.org.uk or via Robert.Frost@acmedsci.ac.uk
Lancet Press Office T) +44 (0) 20 7424 4949 E) tony.kirby@lancet.com
Academy of Medical Sciences, 41 Portland Place, London, W1B 1QH http://www.41portlandplace.com/about/7/how-to-find-us
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The Lancet