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NHS Confederation calls for action to halt decline in UK clinical trials

Efforts to increase the numbers of clinical trials carried out in the UK are being hampered by EU rules and bureaucracy, according to the NHS Confederation's European Office.

In a submission to the European Commission, the NHS Confederation highlights figures which show that the UK's involvement in global clinical trials has "dropped dramatically" since the introduction of the EU Clinical Trials Directive. It says there is an "urgent need" to address the situation if the climate for clinical trials in the UK is to improve.

The NHS Confederation is calling for a more streamlined 'one-stop-shop' approach for organisations taking part in clinical trials, with a faster approval process and fewer variations in the way guidelines are interpreted in different countries. This, it says, will make it simpler to submit a request for authorisation of a clinical trial.

The EU Clinical Trials Directive was introduced in the UK in 2004 with the aim of promoting good clinical practice and harmonising clinical trial activity across the EU.  However, since its introduction there has been a dramatic drop in the numbers of global drugs trials with UK involvement, down from 6% in 2004 to 2% just four years later. This picture is reflected within Europe too - in 2002 46% of EU products in clinical trials were being developed in the UK - by 2007 this had almost halved to 24%.

Figures from the Department of Health also show that the number of mid-stage, late-stage and post-approval clinical trials - which test potential treatments in humans to see if they should be approved for wider use in the general population - fell from 728 in 2008 to 470 in 2009, the lowest level in the past decade. Those figures also showed that early stage trials fell to 210 in 2009, the lowest in five years.

The Government announced in this year's budget that it wanted to make clinical research a major tool in making the UK a more attractive place to do business, and  "radically reduce" the time it takes to get approval for the clinical trials. It also highlighted the substantial economic and social benefits it could bring to the economy. 

In its submission to the European Commission the NHS Confederation's European Office says there is an "urgent need" to improve the climate for clinical trials in the UK and the way NHS organisations participate in them, in order to attract investment and jobs, and help provide patients with early access to new treatments.

There have been some examples - such as the North West Clinical Trials Exemplar - where NHS organisations have worked within the current rules and have in fact increased the numbers of trials being carried out. But such improvements are the exception rather than the rule and the NHS Confederation says organisations need more information about what processes are legally required to undergo if there is to be a significant upturn in the numbers of new treatments being tested in the UK.

In particular, the NHS Confederation is calling for a more risk-based approach, in order to reduce the burden on trials of well-used treatments, which could be used for treating illnesses, other than those they are currently approved to treat. Currently, such treatments are often expected to go through the same regulatory processes as new drugs, irrespective of the risk of the research.

Elisabetta Zanon, Director of the NHS Confederation's European Office, said:

“The rules as they stand are not clear enough. They do not provide NHS organisations with enough clarity about what processes they do and do not need to follow when applying to participate in a clinical trial. As a result the UK's involvement in the global development of new medicines and technologies has stalled.

"This means that everyone in the UK - including the NHS, its patients, and taxpayers - is losing out.

"Clinical trial regulations should always put the safety of patients and those participating in clinical trials first. But the bureaucracy needs to be proportionate to the risk of the trial. What we are calling for is a system that is easier to navigate and gets the balance right. 

"The NHS has a strong history in playing a vital role in the development of new treatments. There is enormous research potential for it to get involved, alongside academic and commercial partners, and deliver a real breakthrough service for patients."

Mike Farrar, NHS Confederation chief executive, added:

"Having been involved in previous efforts to increase the NHS's involvement in clinical research, I am fully aware of how much of a challenge it has been for NHS trusts to establish themselves as real players in the market. But given a better context, we know how committed and successful they could be in delivering real improvements to the speed and reliability of clinical trials. You only have to look at the results from the North West Clinical Trials Exemplar work to see just what the NHS is capable of.

"This revision of the rules is an opportunity to achieve the Government's ambitions to make clinical research a primary driver of national economic growth.

"We need to use this opportunity to help re-establish the NHS as a world leader in clinical research.”

The European Commission's revision of the directive aims to improve the process for organisations taking part in clinical trials. The Confederation's response will feed into the revision of the directive. 

Notes to Editors
  • A recent report by the Academy of Medical Sciences found that it took an average of 621 days in the UK from a decision to support studies through to the first patient entering a trial, compared to Canada’s 30 to 60 day process.
  • In the most recent budget, the government announced plans to set up a new health research regulatory agency to streamline regulation and improve the cost effectiveness of clinical trials. It plans to make future National Institute for Health Research (NIHR) funding to providers of NHS services conditional on meeting benchmarks, including a 70 day benchmark to recruit first patients for trials;
  • The percentage of EU products in clinical development in the UK fell from 46 per cent in 2002 to 24 per cent in 2007;
  •  Figures from the Department of Health show that the number of mid-stage, late-stage and post-approval clinical trials fell from 728 in 2008 to 470 in 2009, its lowest level in the past decade. Those figures also showed that early stage trials fell to 210 in 2009, the lowest in five years;
  • In a summary of responses on the Clinical Trials Directive received in 2010, the European Commission acknowledged that the directive had resulted in "reduced competitiveness on a global scale" for EU member states;

 - NHS Confederation chief executive Mike Farrar was previously involved in the North West Exemplar programme, set up to establish the NHS as a viable environment for commercially-sponsored clinical trials;

The NHS European Office monitor EU developments and influences them in the interest of the NHS. It is part of the NHS Confederation and funded by the strategic health authorities in England. More information and the office's submission to the Commission can be found at www.nhsconfed.org/europe

The NHS Confederation represents more than 95% of the organisations that make up the NHS. Its members include the majority of NHS acute trusts, ambulance trusts, foundation trusts, mental health trusts, primary care trusts, independent providers of NHS services, special health authorities and strategic health authorities in England; trusts and local health boards in Wales; and health and social service trusts and boards in Northern Ireland.

Contact Francesca Reville 020 7074 3312, 07884 473086 or Niall Smith 020 7074 3304, 07767 770309 or James Pritchard 020 7074 3306, 07525 681567.  For out of hours media enquiries, please call the Duty Press Officer on 07880 500726.

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