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Scaling up the UK's research ambition

Published on 15/06/09 at 03:44pm

The UK has always been one of the world's leaders in drug discovery, with around half of all major medicines sold in the country developed in British laboratories.

But for all the success of the UK's pharmaceutical R&D, there is a sense this has been achieved despite, rather than because of the NHS.

For many in the industry, NHS bureaucracy and attitudes are a deterrent to conducting clinical studies in the UK, with a lack of co-ordination, high costs and time delays that make other markets more productive places of work.

This lack of co-operation has contributed to a decline in the country's global standing as place to conduct clinical research.

A global ranking of overall effectiveness for clinical trials, as collated by Thomson, put the UK in equal sixth place with the Czech Republic, after the US, China, India, Russia and Brazil.

Since Labour came to power in 1997, numerous initiatives to cut red tape and bolster UK R&D have been introduced, but have so far failed to advance its position among international rivals; 28% of UK trials failed to recruit patients in 2007.

But the Department of Health's top civil servants say their latest strategy will pay off for the country's research base.

Sally Davies is director general of research and development and chief scientific advisor for the Department of Health and NHS, and has held the post since 2004.

She is optimistic that the government can bring together the NHS, academia, funding bodies and industry to create a reinvigorated world-class research environment.

"Only time will tell, but I don't think it's too late. There will be a place for Britain in the future of clinical research with pharma and biotech."

Davies says there is significant change already underway, but the industry hasn't yet heard about it.

"It's clear that a lot of people don't know of the work going on [in the NHS] and are therefore not accessing it, which is sad. So we'll have to put in a much stronger communications platform to try and make sure they do."

One major new initiative to come from government is the promise to double the number of NHS patients in trials over the next five years, a drive to be spearheaded by Davies and her colleague Louise Wood, deputy director and head of innovation and industry R&D relations.

The initiative sounds at first impressive, but on closer inspection it grows vague; the Department are unable to attach any figures to it, as no national record of the number patients participating in trials has ever been kept.

But Davies and Wood insist they have this, along with many other issues, in hand. They admit no "magic bullet" exists for instant improvement, but are adamant that things are changing for the better.

Davies adds: "What we've now been told by the very top of industry is that we've got the policy right, and what we're beginning to see is that policy paying off. Things are starting to happen on the ground that are making it work."

New initiatives

The industry has long been frustrated with government efforts to improve the environment for research, despite Davies' work over the last five years.

But this spring, she says a number of new policies have come into force that could truly fulfil the need to make conducting trials in England a lot of simpler, faster and cheaper.

On 1 April this year a new single national method for gaining approval to conduct trials with the NHS was launched, and some success can already be seen.

The NIHR Coordinated System for gaining NHS Permission (NIHR CSP) is aimed at standardising and streamlining the process for gaining NHS Permission in England, reducing both approval times and bureaucracy.

The first two industry studies approved under the new system this year took less than 90 days from notification to the first patient visit, compared to an average time of 173 days in 2007.

Davies said: "The early signs are that the turnaround times, which are one of the issues the industry worry about, have been reduced. We believe as the training improves that it will reduce even more."

A central record of the patients involved in trials is also underway, and Strategic Health Authorities (SHAs) are now required to record and report annually the number of patients that enter trials.

This data will be collated nationally and eventually provide a means to measure patient participation, and therefore the success of the Department's efforts to increase it.

The hope is that by reducing trial approval times, the number of patients enrolled will then rise in turn.

Significant new changes to how clinical research is prioritised and managed in the NHS reform have also recently been introduced.

Firstly, the NHS constitution published in January 2009 aims to make research as a core function of the NHS.

The new Health Service Act puts a legal duty on Strategic Health Authorities to promote innovation through a range of measures including research, and means they are required to support the work of the National Institute for Health Research (NIHR).

The NIHR is an infrastructure within the NHS built to improve the co-ordination, speed and funding of NHS research, and allow patients and professionals to join in research studies and trials across the country.

The impact of the new Health Service Act won't truly be seen until next year, but Davies is convinced of its success and benefit to patients.

She explains: "In their legal duty to innovate, SHAs have a role in helping the NHS work with industry and helping deliver trials."

She explains: "In their legal duty to innovate, SHAs have a role in helping the NHS work with industry and helping deliver trials."

"And research indicates that organisations that are active in research also deliver much better health outcomes to their patients."

Roll out for results?

But even with the new initiatives, many on the business side are still negative about progress, and have yet to see results.

Sir David Cooksey, once a venture capitalist himself, has publicly voiced his doubts.

Cooksey led stakeholders in a government commissioned review of the bioscience sector, The Review and Refresh of Bioscience 2015, and concluded NHS efforts to aid research were poor.

Recently addressing the recent BioFinance and BioInnovate conference in London, he said: "The NHS is an incredibly slow and ponderous organisation. It should be the jewel in our crown, but instead is actually perilously close to driving the whole system into ground."

He welcomed the moves to change behaviour in the NHS, though at the same time likened it to "trying to stir treacle".

Wood, as the industry interface at the Department, admitted she has picked up the same response.

But she argues that this will improve when the new policies are properly embedded across the country.

"The implementation of the strategy and the tools have been patchy or slow or incomplete. So the focus now is on what can be done to embed research as a front-line service of the NHS."

To ensure roll out, Wood describes the efforts have been made to engage stakeholders, making it more than new top down guidance.

An R&D leadership forum was recently set up, bringing together people from industry with six Trust chief executives.

One of its key aims is to make clear the benefits of participating in research, namely improved patient care, and working with NHS colleagues to spread an understanding of those benefits.

Wood describes it as one of "the most research active organisations within the NHS in England, which provides a forum for specifically enabling discussions about how we can move the research agenda forward."

North West SHA pilot

To further push the research agenda, the North West SHA is to undertake a pilot study of some of these ideas.

Davies adds: "We're putting in the work effectively and speedily there, to learn the lessons as a way of chivvying the system."

Mike Farrar, the chief executive of the North West SHA and former head of primary care at the Department of Health will lead the project.

The North West has been quick to respond to the drive to improve research in the NHS and is historically good at working with industry, according to Wood.

The region is also closely linked to the UK Clinical Research Collaboration (UKCRC), a partnership of organisations set up in 2005 to help establish the UK as a world leader in clinical research by harnessing the power of the NHS.

The North West is host to all of the topic-specific clinical research networks that gain government funding and support through the UKCRC, and most importantly the networks' access to large patient populations.

Though the networks themselves haven't historically done a lot of work with industry, Wood says they are very keen to get involved.

"It's part of this general strategy of leveraging the great power of the NHS, rather than just working in centres of academic excellence, which are academically excellent but don't have necessarily have access to huge numbers of patients."

Hearts and minds

But attitudes and culture as well as policy must be change in the NHS.

Davies concedes there is also much work to be done in this area. "I think the NHS has to more broadly recognise the role of research; in encouraging industry here, and in solving the questions that we have in delivering patient care. But this is a change management programme for the NHS, the biggest employer outside the Chinese army. The change management programme doesn't just happen like that."

Woods maintains the NHS has already seen attitudes shift.

"On the hearts and minds issue, coupled with all this [infrastructure] from the centre, there is a much greater understanding among Trust chief executives. They understand why it is the British government's strategy and policy to enhance the environment for contract research in the UK."

Too little too late?

It seems both industry and government finally agree that clinical trials can be one of the most cost-effective investments a society can make to improve healthcare, but the concern is it may have come too late.

The lack of NHS enthusiasm as a whole to recruit patients for research may have already driven some companies to take trials outside the UK. Notably, one major global pharmaceutical company has recently decided to downgrade the UK to being a 'non-core' country in terms of trials, meaning that from now on it will only conduct trials here via third-party contract research organisations.

India and other Asian countries offer a much cheaper alternative to the UK, and though they may also be heavily steeped in regulatory bureaucracy, cost is a major factor to companies.

The option of the US and Canada is also appealing to industry, as the approval process is far slicker and it is possible to carry out trials on a much larger scale.

Both locations offer advantages that make it hard to see the UK ever competing globally in clinical research.

One UK leader in pharma research has applauded the new drive from the Department reverse the situation, though admitted regrettably the timing was too late.

But as ever Davies is optimistic in the UK's capabilities and its future. She maintains the country will be a leader, and this will happen in the niche areas of experimental medicine, phase I studies, and complex phase III studies. And this can happen as soon as the NHS is set up to do it.

She concludes confidently: "If we develop in this country a model for drug development, be it small molecules or biologics, then we will be in a very good place to support the research relating to that. I think the future could be very rosy."

Though to echo her own words "only time will tell", and the industry is only likely to only believe it when they see it.

Professor Dame Sally Davies is the director general of research and development and chief scientific advisor for the Department of Health and NHS.

She has actively been involved in NHS R&D from its establishment and is responsible for developing strategies to improve the NHS research pharma partnership and outcomes

As director general, she developed the new government research strategy, Best Research for Best Health with a budget of £1 billion, and is now responsible for the implementation of the National Institute for Health Research (NIHR).

She is a member of the recent Biotechnology Innovation and Growth Team and the Healthcare Industries Taskforce.

Dr Louise Wood is deputy director and head of innovation and industry R&D relations in the R&D directorate of the Department of Health.

She is a member of the directorate's senior management team and works closely with industry trade associations, companies and colleagues in the Department of Health's Industry Sponsorship Branch, UKTI and BERR.

REVIEW AND REFRESH OF BIOSCIENCE 2015

The Review and Refresh of Bioscience 2015 report, led by David Cooksey included the view of Quintiles, a world-leading clinical research organisation with its European Headquarters in the UK.

It said while demand for its services is high, the company experiences great difficulty in accessing patients and with the bureaucracy associated with study approval and start up.

Patient recruitment is a global challenge but the UK has not kept pace with some other countries and regions in terms of identifying and randomising patients. In the UK, accurate feasibility is a challenge, with investigators often overestimating the number of protocol-appropriate patients under their care.

The lack of reliable patient databases compounds this problem, particularly as patients are not routinely requested to pre-identify themselves as being interested in participating in clinical trials. Lack of research time for investigators and support staff, coupled with a lack of requirement to report operational performance, may also contribute to the low level of patient recruitment in the UK.

The time taken for the three-tier approval process and the associated bureaucracy in the UK also need to be addressed, as the time for approval in the UK often exceeds that in other countries. Quintiles supports any industry-wide initiatives that tackle these issues although these must not be pushed through at the expense of thorough and appropriate regulatory and ethical review.

There are signs of progress, however. Quintiles has actively engaged with the UK Clinical Trial Network (UKCTN) initiative and welcomes the £40 million investment in the UKCTN infrastructure. They also look forward to the smooth implementation of the coordinated system for NHS permissions which ought to speed up approvals.

However, if the UK is to remain competitive for clinical development, more needs to be done. One area where Scotland is seen to lead the way is in alerting the general public to the need for, and benefits of, participation in clinical research. The media often portrays the pharmaceutical industry in a negative way. Therefore, there is a need to turn the tide of public opinion if more patients are to be recruited.

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