From bench to bedside revisited

Clinical Research Facilities open their doors

The Trust's Clinical Research Facility initiative, launched in 1997, has come to fruition: the five centres are completed, the staff are ready and the research projects are beginning.

In a recent lecture at the Royal College of Physicians, Professor Jonathan Rees observed: "The discoveries of the last ten to 20 years will remain marginal until we understand once again that discovery made by those caring for patients rather than advance in basic biological science is what is now rate limiting for medical advance." While molecular biology and genetics are booming, and discoveries and insights arrive weekly, classic clinical research appears to have lost some of its lustre and appeal and is in danger of becoming something of a poor relation.

Without clinical research, however, the much vaunted pathway of 'genome to health' will hit a bottleneck and the promise of the Human Genome Project will be unfulfilled. For clinical research provides the essential understanding of why and how people become ill, by characterising human disease in detail, and testing the response of patients to new therapies or methodologies.

Key factors in the decline of clinical research in the UK have been financial pressures on the NHS and healthcare reforms. These have created pressure on beds – patients requiring treatment take priority, leaving no spare capacity. But the fall-off in capacity has been in parallel with a drop in the number of clinical researchers: many clinicians interested in research have gone into the lab to do molecular biology instead, or have opted to stay in clinical practice.

The USA faced a similar problem, although for a different reason: in the US healthcare system, research cannot be carried out in hospital beds because insurance companies, which are responsible for the costs of most healthcare, will not pay for them. The US response was to build more than 70 General Clinical Research Centers – dedicated high-quality facilities in which researchers can work directly with patients – and there are still demands for more.

The UK now has five such centres of excellence for clinical research thanks to the Clinical Research Facility (CRF) initiative, launched in 1997 by the Trust to foster and promote patient-oriented research within the UK. The Trust committed some £18 million to build and equip the units in Edinburgh, Manchester, Birmingham, Cambridge and Southampton, with each facility linked to local hospitals and biomedical research departments in universities. Patients will be studied in newly built or refurbished wards, consultation rooms, day clinics and laboratory facilities which are dedicated to clinical research and kitted out with modern equipment.

While the Trust provided the initial building costs, the funds for day-to-day running costs and clinical infrastructure are being provided by NHS Research and Development monies. "The NHS has been very enthusiastic about the projects," says Dr Howard Scarffe, Head of Programmes for the Trust's Career Schemes and Clinical Initiatives. "We have worked very closely with the NHS R&D in the Department of Health, and they are providing funds at a regional and a central level to support the CRFs. And in Scotland, we're delighted that the Chief Scientist Office of the Scottish Executive is making such a major contribution to the Edinburgh facility."

Building the partnerships between the Wellcome Trust, universities and NHS hospital trusts has been crucial to setting up the facilities. "The CRFs are all about collaboration," says Dr Scarffe. "They have brought the universities and NHS trusts together, and Wellcome has helped facilitate this union. There is also great enthusiasm from all the people working on the five projects. They are collaborating with IT, and meet on a regular basis to exchange information."

Teams of doctors, nurses and biomedical researchers will carry out a wide variety of research at the CRFs, investigating new medical treatments or procedures. Cambridge, for example, will be looking at diabetes and ovarian cancer, Manchester at osteoporosis and tissue injuries, and Edinburgh at heart disease and bowel cancer. "All the clinical research facilities have a different feel to them, with principal investigators looking at different problems," says Dr Scarffe. "And they are not just for Trust-funded research – they are for any academic researchers."

As well as research, the facilities will play an important role in training a new generation of clinician scientists. "Training young doctors in the skills of clinical research is an essential part of the programme," says Dr Scarffe. "As spin-offs from genomics arise, it is important that we have a cadre of doctors who can do clinical research and can translate new discoveries to bedside care."

Eating, sleeping and breathing clinical research
Three years ago, a stroll along the main concourse of Southampton General Hospital would have taken you past a boarded-up corridor concealing old closed wards and offices. These relics of past cutbacks have now been transformed into a Wellcome Trust Clinical Research Facility (CRF), with new laboratories and patient rooms. The unit has been partially open since the first week of July, and the rest of the components will be finished and commissioned ready for the official opening on 26 November.
“We have a comprehensive set of facilities,” says Professor Chris Byrne, Director of the Southampton CRF. “We have ten beds for adults and four for children, outpatient rooms, and laboratories for physiology, environmental studies and molecular biology, to name just a few. We also have 13 dedicated research nurses, whose aim is to facilitate the research effort of principal investigators.”
The research projects at the Southampton CRF include studies of nutrition, sleep disorders, allergy and asthma, obesity, diabetes, heart disease, and liver fibrosis. All the projects emphasise the multidisciplinary approach to research, bringing together the expertise of different principal investigators to address related questions.
Professor Byrne’s own area of interest is the metabolic syndrome that predisposes individuals to type 2 diabetes and heart disease. “Much of our research looks at people who are obese, and how low levels of physical activity are associated with insulin resistance and a predisposition to diabetes and heart disease,” he says. “And we’re looking at it from both clinical and basic science perspectives, using physiological and molecular studies.”
These studies dovetail neatly with those of researchers interested in why low birthweight babies are more likely to develop heart disease and diabetes as adults. For example, Dr Richard Holt and Professor David Phillips are testing the activity of hormones, while Professor Alan Jackson, part of a large nutrition group in Southampton, is investigating whether maternal nutrition influences the size of a baby. “You can see how we all work together as a team,” says Professor Byrne.
The four paediatric beds are being used for studies of allergy in children - headed by Dr Jonathan Hourihane, the Assistant Director of the CRF, and Professor John Warner - and by the respiratory team under Professor Stephen Holgate for related studies of asthma and allergy. In the latter case, the bronchoscopy suite is being used to take tissue from asthmatics so that cells from their airways can be examined.
“Southampton also has large projects in liver disease and hepatitis C, and in sleep disorders such as sleep apnoea (where people stop breathing while they’re asleep),” says Professor Byrne. “The Facility is allowing all of us to do the clinical studies and physiological measurements that weren’t possible beforehand.” Southampton is, for example, one of the few centres specifically equipped to study sleep disorders (Dr Richard Godfrey’s group) with, as Professor Byrne puts it, “a nice bedroom with monitoring equipment and a video camera.” The containment facilities, meanwhile, enable researchers such as Professor Michael Arthur to study hepatitis C virus in laboratory conditions and clinically. “The quality and finish of the Facility is outstanding,” says Professor Byrne. “It’s a very nice environment in which to work.”
Clinical themes at the CRFs
Each of the Wellcome Trust Clinical Research Facilities is specialising in particular areas of human medicine:
Birmingham: endocrinology, immunotherapy and cardiac studies
Cambridge: diabetes and ovarian cancer
Edinburgh: ageing, heart disease, bowel cancer, liver transplants and weight gain
Manchester: tissue injury, gene therapy in vascular disease, osteoporosis, and craniofacial disorders
Southampton: nutrition, food allergies, sleeping disorders

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