The UK is a reigning world champion in clinical R&D. Recently, however, rival contenders from Central and Eastern Europe, Asia and South America landed some powerful blows in offering to perform clinical studies more cheaply, recruit patients more quickly and slash through the red tape.
“An increasing proportion of studies are being performed in emerging countries,” says Craig Stevenson, Director of Clinical Research at Pfizer UK. “Currently, we perform between 5% and 10% of our Phase II and III studies in these countries. However, we conduct about 12% of the global workload in the UK, which has a particularly strong scientific heritage, as well as a good reputation for reliability and delivering on time. The quality of the research and the delivery on time are the most important factors for us when we decide where to run a study. The cost is less of an issue.”
Nevertheless, many drug companies complain of study protocols that gather dust in ethics committees, complex and inconsistent contracting and a declining number of academic clinicians, which have fallen from 4,000 in 2001 to 3,500 today. As a result, numerous commentators have warned that, unless we fight back, UK R&D could soon be out for the count.
“Everyone recognised that we needed to make some fundamental changes to ensure that the UK remained at the forefront of medical research,” says Liam O’Toole, chief executive of the UK Clinical Research Collaboration, an alliance of stakeholders that have developed a co-ordinated approach to boost clinical research.
However, keeping the champion’s belt won’t be easy, as O’Toole acknowledges. “We need to produce structural, financial and cultural change. So we have a big agenda. But it’s really exciting and encouraging how the industry, the National Health Service, the government and other stakeholders have come together in an unprecedented way to shape the research environment.”
British drugmakers have taken a leading role in the UKCRC, for example, several pharmaceutical company executives are on secondment with the UK Clinical Research Network – which we’ll return to later. The UKCRC also has a vocal and influential industry liaison committee. “This allows the UKCRC to deliver what industry needs as part of improving the environment for all involved clinical research,” O’Toole says.
The UK government says its committed to making the country more attractive to pharmaceutical companies, and wants to raise the level of R&D to 2.5% of gross domestic product by 2014. The recently published NHS R&D Strategy Best Research for Best Health is central to its approach.
A new strategy
Under the new strategy, which applies to England only, every patient will be able to participate in clinical studies. (Each devolved administration is developing complementary approaches). The Clinical Research Networks will create a geographically and clinically inclusive infrastructure, while the Department of Health will fund the networks using a population-based model to distribute resources across England. Critically, the NHS will pay trusts directly for the doctors, nurses and allied health professionals needed for R&D. This isolates funding from payment-by-results and offers trusts and primary care organisations an incentive to participate.
There are currently networks in cancer and mental health although several others - focusing on medicines for children, diabetes, stroke, as well as dementias and neurodegenerative diseases - are being established. “The network areas were decided based on health need, the state of research and the extent to which the community can work together,” O’Toole comments.
As these examples show, the NHS strategy aims to make it easier to establish clinical studies by reducing bureaucracy and improving research governance. “This is currently the rate-limiting step in R&D,” says Stevenson, a member of the industry liaison group at the UKCRC. “If we can cut the red tape we’d have gone a long way to improving the UK’s competitiveness in delivering successful clinical studies.”
And the new strategy cuts the red tape at several places. For example, the NHS plans to introduce ‘research passports’ to avoid repetitious credential checks by different health authorities. Meanwhile, a national expert advice service will provide researchers and trusts with advice on interpreting the law.
The strategy also envisages further enhancements to the speed of ethical approval. In 2005, the government published an independent ad hoc review of NHS research ethics committees. The National Patient Safety Agency, which hosts the Central Office for Research Ethics Committees, is consulting on implementation of a package of measures based on the review; these include strengthening the expert support for the ethics committee service, speeding the review of low-risk studies and helping committees improve consistency. This should further propel the benefits that followed the enactment of the European Clinical Trial Directive.
On average, a study now receives ethics approval within 60 days of submission, rather than the six to nine months it used to take.
The new strategy intends to support staff development, as well as offering a more attractive career in R&D to clinicians. For example, there is now pay parity between academic clinicians and their colleagues on the NHS’ wards and primary care. New training programmes and lectureships should increase the number of academic clinicians. In addition, from next year, the National Institute for Health Research will create a faculty offering mentoring and training to help researchers’ career development. More generally, the NIHR will provide a framework that positions, manages and maintains the NHS’ research staff and infrastructure.
As a final example, the DH believes that “the creation of cradle-to-grave electronic patient records, coupled with the fact that almost all the population receives its healthcare via the NHS” offers “unique benefits.” For example, the National Programme for IT, Connecting for Health, should transform the NHS’ ability to recruit patients into clinical trials, as well as gathering data on the health of the population and the effectiveness of health interventions.
Areas for improvement
Despite this promising start, some issues still need improvement. For example, Stevenson was encouraged by the NHS’ commitment to focus on improving staff training. In particular, he says, staff need to better understand and enact their obligations under the new European Clinical Trial Directive. Furthermore, Stevenson adds that the contracting process between the NHS and the sponsors remains “a weakness” and an area that threatens our ability to start trials in a timely manner
The DH intends that the NHS will undertake pivotal licensing studies for industry “on a transparent, full-cost recovery basis” using the National Costings Framework. The DH will publish data for NHS trusts on patient numbers, speed and quality. Against this background, the Pharmaceutical Industry Competitiveness Task Force helped develop a model clinical trial agreement, although this hasn’t been accepted universally among either trusts or sponsors. The contract is currently being revised.
“Introduction of a new model agreement that is universally adopted should be a big step forward,” Stevenson says.
Despite these issues, Stevenson comments that the UKCRC’s initiative has been “a very positive step. It’s early days. We need to translate the good intentions and the concerted effort into reality.” “It’s sometimes hard to realise that we’ve only been working on this for a year,” O’Toole concludes. “But what is exciting is the unprecedented degree to which the partners and wider stakeholders have been prepared to work together to deliver common goals. We still have a lot to do, but with two or three years, the clinical trial environment will look very different.”