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Rapid Responses: Rapid Responses published:
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Biophysical Semeiotics complies with the need of the UK. Academy of Medical Sciences
- Sergio Stagnaro (31 October 2003)
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Resuscitating Clinical Research in the UK
- Sandip Raha (3 November 2003)
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Clinical Research in UK: Is it salvagable?
- G Nabi (3 November 2003)
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Rebirth of clinical research
- Woody Caan (4 November 2003)
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'Researching research'
- Jonathan Grant, Steve Hanney and Martin Buxton (5 November 2003)
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Clinical Research in UK : Why discouraging overseas medical graduates ?
- Anurag Singh (5 November 2003)
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One more barrier: the pre-entry bottleneck
- Michael W.K. Lim (6 November 2003)
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Missing clinical links
- Stephen J Hopkins (7 November 2003)
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Training in clinical trial design
- Carlo Palmieri, Stephen Wanaski, Jens Panse and Bruno Medeiros (8 November 2003)
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The resuscitation of clinical research
- Bo O Norberg, SE-901 85 Umeå, Sweden (21 November 2003)
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Sergio Stagnaro, Specialist in Blood, Gastrointestinal, and Metabolic Diseases. Researcher in Biophysical Semeiotics. Via Erasmo Piaggio 23/8. 16037 Riva Trigoso (Genoa) Italy.
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Sirs, I cannot agree with Bell’s statement, according to which a substantial gulf remains, nowadays, between basic discoveries, really increased greatly, and converting such discoveries into innovations that can be applied to patients (1). In addition, I appreciate that “the United Kingdom was internationally recognised for its contribution to characterising diseases by careful examination and testing in patients”, since I dedicated 46 years of clinical researches in the obsolete field of physical semeiotics, and have founded the Biophysical Semeiotics (See my web site, HONCode 233736, http://digilander.libero.it/semeioticabiofisica). Furthermore, I cannot agree at all with paper’s author when he writes that “the development of methods to investigate the molecular and genetic basis of disease has since shifted research away from the bedside”. That’s absolutely not true; if doctor knows this overlooked, however an half century old, physical semeiotics, he is able to apply in day-to-day practice all new wonderfull achievements, e.g., the knowledge of the basic and sophisticated mechanisms of disease, increased greatly over the past 20 years, as well as to program and perform “clinical” researches, that the instrumental semeiotics, without any doubt expensive and not to be applied on very large scale, is not able to carry on. For example, Biophysical Semeiotics allowed me to describe the Single Patient Based Medicine (1), I’ll next post in my web site, which represent a great event beside EBM, and the discovery of diabetic, dyslipidemic, arteriosclerotic, hypertensive, a.s.o., biophysical semeiotic constitutions, of pivotal importance in primary prevention (See in above-cited site URL http://digilander.libero.it/semeioticabiofisica/constitutions.htm), including the “Oncological Terrain”, conditio sine qua non of oncogenesis (http://digilander.libero.it/semeioticabiofisica/oncologico.htm http://digilander.libero.it/semeioticabiofisica/Oncogenesi.htm). There is an urgent need of new methods of diagnosis to reach the goal of the Academy of Medical Sciences: Biophysical Semeiotics is certainly one. 1) Bell J. Resuscitating clinical research in the United Kingdom BMJ 2003;327:1041-1043 (1 November) 2) Sergio Stagnaro “Single Patient Based Medicine” versus EBM.(16 May 2003) http://bmj.com/cgi/eletters/326/7398/1048#32299 Competing interests: None declared |
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Sandip Raha, Associate Specialist Princess of Wales Hospital, Bridgend, CF31 1RQ
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I agree overall with Prof. Bell about state of clinical reasearch in UK. If only Dept. of Health included research as star rating requirement for the Trust hospital (average non- teaching DGH) in UK. Our trust has £10000 for the R&D fund for two acute hospitals with over 70 million annual budget!! And research proposal has to submitted every year in a rush of two weeks at the Trust R&D committee comprising of people with very little or nil experience of Research. Any cost involved of the Trust facilities (including clinician or prefessional's normal working hours)has to be costed and how the proposals would or not use Trust facilities has to be explained, are these enough deterant to do research for busy and overworked clinicians? Whole culture adopted by Govt. and Trust has to change before more research is possible in Trust hospitals. We have R&D in our trust (I being one of the members!) and I also run a small Care of The elderly Research group which basically does Audit and service developemnt rather than pure research. On other point many large research funds have significant waste and mismanagement in their process. Why don't we have economic evaluation and cost effectiveness of many large research grants like we have for many service developments in NHS? Competing interests: None declared |
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G Nabi, Clinical lecturer Surgery Aberdeen
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Dear editor I read with interest the article on resuscitating clinical research in the United Kingdom by John Bell1. He has rightly pointed out the core issues involved in the shift of focus from clinical to basic research. However, following issues remain to be looked into: 1. Considering the fact that there is an acute shortage of doctors both at general practice and specialist level in NHS at present, what should be emphasis point of research for doctors in-training? If we are able to define it, then the next question would be reward mechanism for individuals dedicating to the development of research. At present most doctors undertake research at the entry level to specialist training and there is not enough motivation to continue it as career due to various reasons. Most of them do not write their theses after they achieve their goal. 2. There is no mechanism to pick up research minded young doctors in NHS and groom them into competent researchers. My suggestion would be to have national level body of eminent clinical researchers with a structured research programme and a competitive level entry into it. When I speak to my colleagues who had some time spent in research, the main disappointment they had is the lack of good supervision during their tenure and of course lack of resources and fundings. These are some of areas, which need to be improved in order to make clinical research attractive and rewarding for doctors. G Nabi Clinical Lecturer, Department of Surgery Medical School, University of Aberdeen, AB25 2 ZD Refernces 1. Bell J . resuscitating clinical research in the United Kingdom. BMJ 2003;327: 1041-1043. Competing interests: None declared |
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Woody Caan, Professor of public health APU, Chelmsford, Essex CM1 1SQ, UK.
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EDITOR: Prof. Bell has done a great service in raising the urgency with which a strategic re-think of clinical research is needed (1). It is three years since very similar recommendations were published by Prof. Peckham's Foresight panel, including for example "a national strategy for clinical trials" (2) but rather than showing progress, these years have seen further deterioration in health science for practice. Efforts by the National Health Service, Research Councils and Health Charities to plan together strategically, have been undermined by a rogue stakeholder, the Higher Education Funding Council for England, that has been determined to do its own thing. As HEFCE puts it, in its latest Review (3), "there is no similar mechanism for encouraging collaboration between HEIs and research organisations outside the HE sector" i.e. in healthcare. Whereas the NHS makes a massive contribution to teaching and learning for Higher Education, HEFCE simply will not consider the diverse development needs of teaching hospitals and primary care trusts. If home-grown research is to thrive, we "cannot afford to look back nostalgically" to past roles (4). Published clinical research is overwhelmingly produced by teams, and clinical teams include nurses and allied health professionals that should contribute as partners (not handmaidens) to innovative research. Even more crucially, for the future of clinical research, patients should influence and be seen to influence research funding and the uptake of research findings. Good preliminary work has recently been demonstrated here by Involve (5). 1. Bell J. Resuscitating clinical research in the United Kingdom. BMJ 2003; 327: 1041-3. 2. Foresight Healthcare Panel. Health Care 2020. London: Department of Trade and Industry, 2000. 3. HEFCE. Review of research funding method. Bristol: Higher Education Funding Council for England, 2003. 4. Caan W. Voluntary register must embrace the new public health agenda. Public Health News 2003; 8 September: 7. 5. Involve (formerly Consumers in NHS Research) website www.invo.org.uk Competing interests: Member of the Academy of learned societies for the Social Sciences; member of the Representative Group of the NHS R&D Forum. |
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Jonathan Grant, Associate Programme Director RAND Eurpoe, Grafton House, 64 Maids Causeway, Cambridge, CB5 8DDs, Steve Hanney and Martin Buxton
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We read with interest the series of papers in the current issue of the BMJ advocating funding for clinical research (1, 2) and support the view that such advocacy needs to become evidence based. Two recent reports (3,4; see http://www.brunel.ac.uk/depts/herg/pubs/internal.html) explore the relationship between basic research, clinical research and clinical practice. In the first, which attempts to replicate Comroe and Dripps’ seminal study as reported in Science in 1976 (5), we trace back from current clinical practice to the knowledge behind the advance. Comroe and Dripps concluded that two-fifths of all research articles judged to be essential for later clinical advance were not clinically orientated at the time of the study and that 62 percent of key articles reported basic research. Their paper has often been used (albeit at times implicitly) in support of the increased funding for basic biomedical research in the UK and elsewhere over the past two decades. We found we were unable to repeat the study methodology, thus confirming earlier doubts about it (6) and raising questions about its reliability, validity and, more importantly, its applicability, at least for current circumstances. In recognising the difficulties in tracing backwards from clinical practice, we have undertaken a preliminary study that attempts to work forwards by tracing the impact of a range of research conducted 20 years ago. In this study we explore a number of methodologies that could assist in the identification of the benefits from previous research and thus potentially be used to develop an evidence base to support R&D funding decisions. Our work has only begun to scratch the surface of this important but complex issue, nevertheless, we would argue that research funding agencies should accept the need for a firm evidence basis for their policies and therefore support ‘researching research’ (as Richard Smith termed it in 1987). (1) Smith P. Improving clinical research. BMJ 2003; 327: 999-1000. (2) Bell J. Resuscitating clinical research in the United Kingdom. BMJ 2003; 327: 1041-3 (3) Grant J, Green L and Mason B. From bedside to bench: Comroe and Dripps revisited. HERG Research Report No. 30. Brunel University, 2003. (4) Hanney S, Frame I, Grant J, Green P and Buxton M. From bench to bedside: Tracing the payback forwards from basic or early clinical research – A preliminary exercise and proposals for a future study. HERG Research Report No. 30. Brunel University, 2003. (5) Comroe JH, Dripps RD. Scientific basis for the support of biomedical science. Science 1976; 192:105-111 (6) Smith, R. Comroe and Dripps revisited. BMJ 1987;295:1404. Competing interests: The authors are in recepit of research grants from a variety of funding agencies. |
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Anurag Singh, Clinical Research Fellow BS10 6TJ
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I agree with Professor Bell and he has rightly pointed out the important issues regarding current funding in clinical research. But, from my personal experience would like to touch on an important issue which has probably never been highlighted before. As we know, due to the shortage of doctors at the specialist and primary care level, the NHS relies heavily on the overseas medical graduates (OMD) which, form at least 20% of the current NHS junior medical workforce. Inspite of working in the NHS for the number of years, they are expected to pay huge sums of money as overseas tution fees to register for an MD or a PhD, costing £18000 to £20000 per year. This has lead to low morale and active discouragement among the OMD like myself who, want to pursue academic carrer and contribute to clinical research since the funding bodies do not pay for such expenses. I am facing a similar battle with the University of Bristol and therefore unable to register for a PhD due to the costs. Isn't this discrmination against the overseas graduates to enter the academics? This is an extremly frustrating situation and the NHS and the universities should create a separate bursary for OMD's which pays the difference between home and overseas tution fees, and is offered on merit basis. Competing interests: None declared |
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Michael W.K. Lim, Research Fellow, Nuffield Dept of Anaesthetics Oxford OX3 9DU
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As a SpR who successfully applied for research funding, I would add the shorter SpR training and the general shortage of doctors in the NHS to Prof Bell's list of factors detrimentally affecting research. The time-limited SpR training meant that I had only a limited window to write up and submit applications. Yet over-stretched departments were often reluctant to grant study time to work up those applications. From their perspective, there was little to show for the time granted (that is, no audits and no papers). There was little central support at the Deanery, occupied with the task of shoring up clinical training against competing demands. These remain systemic problems affecting a little publicised bottleneck into research: at the application and pre-entry point. Judging by how well the NHS is handling its current manpower problems, I seriously doubt these problems can be overcome in the near future. I suspect clinical research will remain moribund for a while yet. Competing interests: I have a Research Fellowship from the British Journal of Anaesthesia and Royal College of Anaesthetists |
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Stephen J Hopkins, Principle Scientist, Hon. Sen. Lect (Uv Man); Chair, Assn of Researchers in Medicine & Science Injury Research, Clinical Sciences Building, Hope Hospital, Salford, M6 8HD
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Professor Bell’s article (1), together with the recent Academy of Medical Sciences report (2) and BMJ editorial (3), helpfully outlines the decline in capacity to undertake clinical research and provide a useful wake-up call. As identified in the editorial (3), an important issue is the way in which NHS R&D funding is disbursed, since the previous NHS R&D reorganisation went only part way in separating this support from routine clinical care. An additional aim of that reorganisation was the creation of a culture that values research as part of the NHS and this has not worked as effectively as it might either. While the Research Assessment Exercise was promoting a re-evaluation of the role of clinical staff with academic appointments, the system as a whole did not recognise sufficiently the important role of those clinicians that may not be able to devote large amounts of time to intellectual input or detailed practical research detail, but were both willing and critically able to support such activity. But there is another category of researchers that is sadly not mentioned in the Academy report, and this is particularly surprising given they were the focus of an Academy report in February last year (4). This report dealt with non-clinical scientists in medical research. Its main focus was to urge that more be done to support those on short-term contracts in medical research, suggesting that ‘an imaginative approach is required to questions of funding long-term posts for contract research workers’. However, a major section of the report focused on the problems that all non-clinically qualified research staff face when working in a clinical environment, and the advantages of them being there. These researchers, employed by both universities and the NHS, contribute significantly to the clinical research effort and deserve greater consideration in the debate about clinical research. Not only do they experience many of the same difficulties as their clinical colleagues but, as highlighted in the earlier report (4), they were found to experience other difficulties too. These include the kind of ‘exclusion’ that has occurred in the most recent report (2). A common issue for clinician and non-clinician scientists in a clinical environment is that pressures to encourage a move towards more basic research affected them both. Combined with this movement of research activity has been some degradation in the environment that encourages experimental research in a clinical environment. The recent establishment of new Clinical Research Facilities address this to a degree. But to a significant extent they are not where the patients are, and they lack the infrastructure that might be provided in well-resourced and organised teaching hospitals, with access to a range of good laboratory and investigational resources. It is to be hoped that any moves towards redressing the balance and correcting the decline in clinical research will avoid the attractions of fashion and bandwagons, on which some rely to build their careers, in favour of a more integrated approach that will engage all areas of activity and all parties. 1. Bell J. Resuscitating clinical research in the United Kingdom. Brit Med J 2003;327:1041-3. 2. Academy of Medical Sciences. Strengthening clinical research. http://www.acmedsci.ac.uk (Accessed November 2003). 3. Stewart PM. Improving clinical research. Brit Med J 2003;327:999- 1000. 4. Academy of Medical Sciences. Non-clinical scientists on short-term contracts in medical research: a report on career prospects and recommendations for change. http://www.acmedsci.ac.uk (Accessed November 2003). Competing interests: None declared |
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Carlo Palmieri, SpR Medical Oncology Dept of Cancer Medicine, Hammersmith Hopsital, Du Cane Road, London, W12 0NN, Stephen Wanaski, Jens Panse and Bruno Medeiros
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The articles by Stewart (2003) and the Academy of Medical Science (2003) clearly highlight the problems facing clinical research in the UK and lays out a plan for improving the current situation. However, while it is acknowledged that more clinical academics are required to carry out patient orientated clinical research no mention is given to the crucial area of training in clinical trial design. Such training in the conception, design and management of clinical trials is fundamental to effective clinical research and vital if we are to prevent delays in the introduction of new treatments and to ensure that opportunities are not missed, it is also an ethical obligation given that patients participate in clinical trials based on the assumption that they are entering a sound scientific project. As a result of the deficiencies in oncology clinical trial training the American Association for Cancer Research (AACR), the American Society of Clinical Oncology (ASCO) and the Federation of European Cancer Society (FECS) recently established an innovative and unique workshop for oncology trainees entitled 'Methods in Clinical Cancer Research.' These workshops, held annually in Vail, USA and Flims, Switzerland, teach the principles and practice of clinical trial design and implementation. The cornerstone of these workshops is the writing of a clinical research trial protocol by the participants, which they are then expected to be directly involved in instigating and managing on return to their local institution. (Palmieri et al., in press). We would urge the Academy of Medical Sciences to add an additional recommendation to their list, that of the establishment of a mandatory national scheme for the education of clinical scientists in clinical trial design based upon the successful AACR-ASCO-FECS workshops at Vail and Flims. Such a scheme would help to ensure that the next generation of clinical investigators are as well equipped as possible to meet the therapeutic opportunities that lie ahead. Reference: (1) Stewart PM, Improving clinical research. BMJ 2003; 327: 999-100. (2) Academy of Medical Sciences. Resuscitating clinical research in the United Kingdom. BMJ 2003; 327:1041-3. (3) C. Palmieri, S.Wanaski, J. Panse, B. Medeiros. The future of clinical cancer research: who’s teaching the next generation? The Flims- Vail model. (In press, Eur J Cancer). Competing interests: None declared |
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Bo O Norberg, Associate Professor Department of Internal Medicine, University Hospital of Northern Sweden,, SE-901 85 Umeå, Sweden
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Clinical research is complex. The gap between clinical observations (cf 1) and biomolecular interpretation is often wide. I imagine that one major role for patient-associated physicians is to provide basic research with adequate pictures of disease. One attempt to resuscitate clinical research might be to steer research nurses and research paramedicals into salaried medical studies after dissertation. These persons have usually a broad and deep knowledge of scientific methods from behavioural sciences. After dissertation, they now often turn to teaching, administration, or research careers, away from patients. If reward gradients guided them to GP positions in primary health care, they would have the chance to contribute to the renewal of clinical research. The idea is analogous to the concept of Moshe Dayan, who once made the Israeli army competitive; the best brains should not decay behind a desk in an office. Instead, Dayan sent them to the frontier for sorting, in evolutionary terms “the survival of the fittest”. Reference 1. Norberg B. Gender inequality - hereditary vascular risk [health]. Rondel 2003; 17. URL: http://www.rondellen.net Competing interests: None declared |
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