“This is a unique moment,” says Sally Davies, director of Research and Development at the Department of Health and Chair of the UK Clinical Research Collaboration.
The government, the main organisations that fund British research, the National Health Service, academia, regulators, the pharmaceutical industry and patients are all working together on a co-ordinated agenda to boost clinical research in the UK, and the new NHS R&D strategy - published in January this year and entitled Best Research for Best Health - aims to make participation straightforward for sponsors and trusts.
Punching above its weight
The UK has punched above its weight in medical research for decades. British laboratories have developed around half of the major medicines now sold in the UK, including pharmaceutical landmarks such as the blood pressure drug propranolol, the antiulcerant cimetidine and sildenafil, the active ingredient in Pfizer’s blockbuster erectile dysfunction medicine Viagra.
However, in recent years, researchers in Central and Eastern Europe, Asia and other countries have begun to challenge the UK’s position at the vanguard of clinical research. In part, the promise of lower costs helped drive the migration of studies out of the UK. “We never were and never will be the cheapest place to perform clinical research,” Professor Davies admits. However, she argues that the industry should look beyond cost alone to ‘added value’ – and that’s where the UKCRC and DH can make a difference. “We will ensure the speed, quality and reliability of our clinical studies, and the training of our staff is unsurpassed,” she says. “The knock-on, cumulative effect of this will ensure that costs will come down in the future.”
A raft of changes should enhance the speed, effectiveness and efficiency of clinical research in the UK. In March 2005, for example, Gordon Brown announced a 10-year strategy for science in which spending will increase by £100 million a year to 2008; by then, the UK’s publicly-funded research budget will be £1.2 billion annually. Meanwhile, the DH is refining a model clinical trial agreement, developed by the NHS and the pharmaceutical sector, which trusts will implement. Best Research for Best Health sets out how the DH will spend over £650 million a year to deliver what it terms “high-quality, patient-based research.” For example, every patient in England will have the opportunity to participate in clinical studies. Furthermore, the National Institute for Health Research, the National School for Primary Care Research and NHS research networks across England should enhance the health research infrastructure. Other elements include the introduction of so-called research passports to avoid repetition of credential checks by health authorities and a national expert advice line that will provide 24/7 advice to researchers on interpreting the law.
The benefits of this concerted effort are already beginning to show. Until recently, delays in obtaining ethics approval slowed many clinical studies, one factor that encouraged the migration of trials abroad. However, the enactment of the European Clinical Trials Directive means that ethics committee approval should apply to any centre, if the latter has the staff and infrastructure to perform the study. The UK’s ethical approval system is now web-enabled and companies can monitor time lines.
“The time between submission and agreement has dropped dramatically,” Professor Davies comments. On average, a study now receives ethics approval within 60 days of submission, rather than the nine months it used to take.
Networks for research
As mentioned previously, the DH is funding changes to the UK’s research infrastructure. For example, the UK Clinical Research Network and the UKCRC are creating an infrastructure that supports the conduct and delivery of a range of high-quality studies across the NHS. There are currently networks in cancer and mental health, while several others are being established that focus on medicines for children, diabetes and stroke, as well as dementias and neurodegenerative diseases.
“There are many successful researchers in primary care and district general hospitals, but they’ve been rather quiet up until now,” Professor Davies says. “We intend to build on the success of these groups and run more Phase III studies in primary and secondary care.”
In the future, she explains, academic centres will also focus more on Phase I and II studies, as well as on so-called translational medicine - the point at which research moves from the bench into humans.
The DH is working with other UKCRC partners, including The Wellcome Trust, Medical Research Council and Cancer Research UK, to invest more than £100 million in funding translational medicine, which covers the capital and running costs of several experimental medicine units. But, despite the considerable investment, Professor Davies reports that they still had to turn down some excellent proposals from British researchers. “The excitement surrounding the experimental medicine proposals is palpable,” she comments.
Meanwhile, NHS R&D in all trusts is isolated from the ‘payment-by-results’ that increasingly funds secondary care: the NHS pays trusts directly for the doctors, nurses and allied health professionals needed for R&D. Furthermore, there are numerous initiatives to increase the number of academic clinicians, who have declined 14% in numbers over the last three years. For example, there is now a parity of pay between academics, clinicians and their colleagues on NHS wards and in practice, while new training programmes and lectureships, funded by the DH and several charities, should also increase the number of researchers. The NHS will pay for up to 250 clinical fellowships and 100 lectureships per year.
Additionally, the Higher Education Funding Council for England is working with the DH to fund up to 200 ‘new blood’ senior lectureship positions. Apart from facilitating research, the approach will also offer pharmaceutical companies a new generation of key opinion leaders.
The UKCRC plans several other initiatives to aid research. Firstly, the NHS is almost unique amongst health services worldwide in that GPs care for almost all patients from the cradle to the grave. Best Research for Best Health envisages collaboration with the National Programme for IT/Connecting for Health to help ensure that data collected from the NHS meets researchers’ needs and enables patients’ participation in clinical trials. Professor Davies comments that the planned integrated patient medical record will offer a very powerful tool for researchers.
Secondly, the UKCRC is working on a number of metrics and benchmarks to assess the activities being undertaken. Timelines - for ethics and research approvals - are already available and the UKCRC is currently refining other data, including the number of studies and patients enrolled. “This work is well underway and should be completed by Easter,” she says.
It’s an exciting and unique time for researchers: for once, government, the public and voluntary sectors, as well as the pharmaceutical industry, are working together to a common end. It’s a model that could represent best practice in other difficult areas.
“The fact that so many stakeholders have signed up is a mark of the confidence they have in the UKCRC,” Professor Davies concludes. “Indeed, the changes we’ve already made are beginning to make a difference.”
by Mark Greener