Charities and governments tackle clinical research crisis

Laboratory scientists may grab all the headlines — especially as the human genome project enters the final straight — but policy-makers and researchers on both sides of the Atlantic are increasingly aware of a growing crisis in clinical research.In a commentary to be published in the October issue of Clinical Medicine, Jonathan Rees, Professor of Dermatology at the Royal Infirmary Edinburgh, argues that the discoveries of the past 10 to 20 years will remain marginal unless, "we understand that it is the discoveries made by those caring for patients rather than advances in basic biological sciences that is now rate limiting for medical advances."In a bid to bolster clinical research, the Wellcome Trust is pouring £22 million into five new clinical research facilities that will open before the end of the year. At the same time government bodies in the UK and US are introducing fellowships for clinical research and schemes to help those qualifying both clinically and as researchers to repay the crippling debts they accrue during years of study.Clinical research, as opposed to lab-based basic research, includes epidemiology, clinical trials, health services research and individual patient studies. Work focussing on individual patients is based on applied physiology, clinical observation and patient experience. For example, large simple studies of clinical examination would assess the validity of bedside techniques. Clearly without answers to such basic questions, technological advances cannot meet clinical needs in the real world.Clinical Medicine estimates that as little as five per cent of research funds is allocated to research on individual patients. And even when funds go to clinical research, they are funnelled to epidemiology rather than individual patient studies.The situation in the US is little better. During the past 15 years, the proportion of 'physician-scientists' has declined from 4.2% to 1.8%, according to an editorial in Science signed by the research directors of several US medical charities and research organisations. This reflects a decrease from 23,214 to 14,357 of doctors whose primary career is research, of whom only a minority now conduct patient-oriented studies.Several factors underlie the decline. In the UK, financial pressures on the National Health Service (NHS) and healthcare reforms during the past decade have left little spare capacity for researchers, while in the US, managed health care and steep reductions in medical reimbursements by government limit resources for clinical research. Then the educational debt burden of many medical graduates — especially in the US — makes a research career less appealing because it's generally less well paid than clinical practice.Given such barriers to clinical research, medical charities and government on both sides of the Atlantic had little choice but to intervene. In the UK, the Wellcome Trust decided around 1996 find a way to put its considerable financial muscle to work to strengthen clinical research in the NHS. "Successful clinical research is about getting all the people with expertise in one place. Too often they are spread around a hospital. You need to get all the special support — such as proper research nurses, data management, and vetting by a scientific committee — together so that the research is done at the highest standard," explains Howard Scarffe, Head of Programmes at the Trust.Five new Clinical Research Facilities will open in the UK this autumn, focussing on a range of therapeutic areas: Birmingham (endocrinology, immunotherapy, vasculitis and cardiac studies), Cambridge (diabetes and ovarian cancer), Edinburgh (heart disease and bowel cancer), Manchester (osteoporosis and tissue injury) and Southampton (food allergies and sleeping disorders). The Trust provides the buildings and equipment, while the NHS meets running costs, having already committed £4.47 million to keep the initiatives operating until March 2002.The Trust also supports physicians, through its various award programmes, "We're aware that many of our fellowships over the past decade or so have gone to medically qualified people working in laboratories on molecular biology, but we are now trying to encourage people to take their research training clinical work," says Scarffe. Nor is the Wellcome Trust alone in its concern for the health of clinical research. The Leukaemia and Lymphoma Society has established a number of awards, such as its scholars and clinical research programme, to support physicians wishing to move into clinical research. The public purse, too, is being tapped to promote clinical research. The UK's Medical Research Council has a Co-operative Group grant intended to create a critical mass by fostering collaborations between clinical researchers in isolated environments and is investing heavily in career awards intended to make up for the fact that UK medical education makes little provision for research training.In the US, many of the leading medical charities and the National Institutes for Health (NIH) have research grant programmes to support physician-researchers. For example, The Cancer Research Fund of the Damon Runyon-Walter Winchell Foundation includes an element of debt-repayment in its newly established Clinical Investigator Awards (the US Congress is now supporting moves to include a similar element in NIH awards), which Eli Lilly is financing to the tune of $15 million over five years. "We did not yet have a flood of applicants for these awards, and there is still a problem in finding appropriate mentors. This should not have surprised us – the physician-researchers are a dwindling species. But we are hoping this will change for the future," says Amy Francis, the Foundation's Research Director. If it does, it will not be a moment too soon. If the massive public investment in the human genome project is to translate into clinical benefit, it is time to put the machinery in place to promote the transition from bench to bed.

Charities and governments tackle clinical research crisis

New initiatives in the UK and US aim to create an environment more conducive to enabling doctors to train as 'physician-scientists'.

Aug 20, 2001

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