1.  The Royal Academy of Engineering welcomes the Cooksey Review and hopes that implementation of its recommendations will help to align medical research with health priorities in the UK. The Academy submitted a response[4] to the Cooksey Review based on the views expressed by its Fellows. This evidence is based on that response.

  2.  It is thought that some important issues should have received a deeper analysis and that implementation of the Report's recommendations without a fuller consideration of their implications will neglect other important areas of medical application and might actually damage the UK's excellent biomedical science base. These issues are identified in the points argued in the following paragraphs (highlighted in italic).

  3.   The Review is far from comprehensive, in that the discussion is limited almost entirely to conventional drug discovery and testing. The Report appears biased toward the interests of the pharmaceutical sector rather than representing all the approaches to health research and all the major players. Notwithstanding the importance of pharmacological treatments, clarification of the excessive emphasis on technologies for drug discovery and the regulatory approval of new drugs would be welcomed. In particular, it is asked whether engineering based health technologies will get sufficient representation on the governing board of Office for Strategic Coordination of Health Research (OSCHR).

HEALTH TECHNOLOGIES

  4.  The Academy wishes to draw attention to the importance of forms of medical treatment other than drugs, ie medical devices and health technologies. These have diverse applications, ranging from diagnostics to brain-machine interfaces. In the last few decades biomedical engineering has been enormously prolific. The development of such technologies is an important feature of translational medical research and many technologies have found rapid application in clinical practice.

  5.  Modern medicine is underpinned by biomedical engineering. Some examples of groundbreaking technologies developed for medical applications are:

—  Magnetic Resonance Imaging, for which Sir Peter Mansfield shared the Nobel Prize in Physiology and Medicine in 2003.

—  Computerised Tomography, for which Godfrey N Hounsfield shared the Nobel Prize for Medicine in 1979.

—  Neurobionics (artificial limbs controlled by transduction of activity in the patient's brain), which will allow amputees (and those victims of the 7 July bombings who lost limbs) to regain some of the lost motor functions. This technology is still in development and in clinical trials, but is likely to progress to clinical application very soon.

—  Assistive technologies of other sorts help to overcome the restrictions cause by physical and neurological handicap of various forms.

—  Tissue engineering, using novel biocompatible materials, sometimes combined with cultured stem cells or differentiated cells, is gaining application in many areas of medical treatment.

—  Novel transduction devices are being increasingly applied in diagnostics.

—  Advanced operating theatres are being equipped to perform computer-guided surgery, remotely operated by experts.

  6.  The UK can claim the origin of many such ideas but too often they have been exploited in the United States and elsewhere, where they have been turned into profit-making applications. Magnetic Resonance Imaging is a prime example: the methodology was developed in this country, and the prototype machines were built here, but there is now not a single UK-based manufacturer. Clarification as to why medical devices and health technologies, which are such an important and promising area of health research, were not fully considered in the Cooksey Review would be welcomed.

  7.   In addition, while the review recognises the need for a new Drug Development Pathway (Chapter 8), the challenges faced by the developers of medical engineering technologies are no less demanding and substantially different. An initiative to develop a similar focus on the medical engineering pathway should be considered simultaneously.

  8.  Biomedical engineering is by definition a highly interdisciplinary research area and is underpinned by the most diverse blending of disciplines including medicine, engineering, physical sciences, materials, computer science, robotics and even social sciences. Clearly, MRC and DH R&D alone cannot provide all the resources needed to secure advances in this crucial area. Other Research Councils (ie EPSRC; ESRC) and the industrial sector have an important role to play. Hence, it is felt that the Review discusses too narrow a concept of health research rather than setting wider horizons for the change of culture that the Review would like to see happening within MRC and DH R&D in terms of interdisciplinarity, translation and innovation. Clarification of the lack of discussion regarding the role that important players other than MRC and DH R&D may play in delivering the objectives set by the strategy recommended in the Review would be welcomed.

TECHNOLOGY ASSESSMENT

  9.  There is some concern that expectation of Health Technology Assessment (HTA) in terms of its ability to provide prospective evidence of value is unduly optimistic (see Chart 7.1). If the HTA programme is to perform this role, it will be necessary to ensure that the programme will have both the methodologies and the capacity to be able to deliver this role: its traditional role has been in providing an evidence base on the relative effectiveness of existing health technologies. It is not clear that HTA can take this on without significant changes: a more creative approach to this development stage should be based on developers of new technologies working in partnership with potential users in assessing value (see also the comment in para 7.49).

PREVENTION

  10.  In the USA, the "NIH Roadmap", the initiative aimed at delivering translational research, focuses on effective prevention strategies as well as new treatments (para 3.4). By comparison, the Cooksey Report adopts a narrower definition of translational research which gives little recognition to prevention as a strategic health objective. Rather, it is focused on facilitating the movement of new drugs to the market. The Report identifies the largest future health challenges as cancer, mental health, chronic and degenerative diseases, cardiovascular diseases, metabolic diseases and, within the context of international health, tuberculosis, malaria and HIV/AIDS. Diet and lifestyle play at least a part in the aetiology of most of these disorders and preventive measures could provide a very effective strategy.

  11.  The economic impact of successful prevention would be enormous. The importance of developing effective new drugs and the value of the UK's pharmaceutical sector are acknowledged. However, the Report seems aimed at addressing the current business problems of the pharmaceutical industry and encouraging those companies to conduct clinical trials in the UK, rather than strengthening health research as a whole. Why is there not more emphasis on increased public investment in epidemiological research and its underpinning methodology, in basic studies of gene-environment interaction in the aetiology of complex disease, and in research on social and behavioural determinants of health-related diet and lifestyle? It is not clear why the Review has focused so intensely on the needs of the pharmaceutical industrial to the neglect of the importance of prevention.

CLINICAL TRIALS

  12.  In para 6.25 it is stated that "the Report has not been able to carry out an economic analysis of the costs and benefits of attracting clinical trials to the UK" and that "There is a general lack of rigorous analysis of costs and benefits in this area". In subsequent paragraphs (7.20-7.23) it is argued that in the UK, small biotech and pharmaceutical firms face difficulties in attracting capital when this is most needed ie early stages of clinical trials, because UK venture capitalists are more risk-averse than their US counterparts. In addition, public investment in clinical trials in the UK is said to be modest. However, there is little evidence that those countries, such as the USA, in which there is more trial activity, gain economic benefit from it. Notwithstanding this lack of evidence, the Report recommends a substantial increase in investment of public funds to facilitate translational medicine (defined mainly as clinical trials), one of the principal aims being to encourage the pharmaceutical sector to conduct more clinical trials in the UK rather than across the Atlantic and elsewhere in the world. This recommendation is not supported by evidence that increased trial activity is likely to occur, nor that it would be sufficiently beneficial to the UK economy. On what grounds can it be assumed that the pharmaceutical and biotech industries would increase clinical trials activity in this country to an extent that would justify the level of public investment recommended?

RESEARCH IN CLINICAL SETTINGS AND TRAINING

  13.  Para 4.24 states that "the current funding levels for basic science should be sustained" and recommends that "future increases in funding should be weighted towards translational and applied research until a more balanced portfolio is achieved". However, the Report does not clarify how translational and applied research of high quality will be delivered in practice and what the optimal balance between basic, translational and applied research is. What evidence is there that increased investment in translation and applied research, without a parallel increase in basic funding, will yield better economic and health benefits, in the long run? Also, the Report makes its recommendations for changes in the balance of research on the assumption that the UK has the skill base to deliver translational and applied research of appropriate quality. These areas of research are notoriously difficult and the Report acknowledges that no country in the world has found a solution. Particular skills are needed and few individuals at present have such skills and experience. Where will appropriately trained researchers come from to deliver a significant increase in applied and translational research of sufficient quality to have impact? The Report acknowledges that research in clinical settings has declined in priority within the NHS because of massive pressures to deliver front line services (para 1 Foreword). Clinical training provides little time or incentive for training in research. Although implementation of the Walport Report, Modernising Medical Careers[5] is aimed at addressing this problem, it is likely to be many years before the decline of academic clinicians is reversed, and even longer before substantial new capacity can be built for high-quality clinical research. Translation is even more problematical, since it often requires very unusual combinations of skills and experience. In light of the recommendations in the Report, more consideration should be given to measures to address the lack of skills necessary to deliver the proposed objectives.

INTERDISCIPLINARY RESEARCH AND TRAINING

  14.  Translational research requires interdisciplinary skills that allow researchers and clinicians to communicate. With the exception of very few, unusually experienced senior scientists, researchers trained according to conventional routes struggle to gain sufficient understanding of disciplines other than their own to be able to recognise the opportunities of interdisciplinary working. Commonly, researchers have misconceptions and misunderstandings about what scientists from other backgrounds actually do, how they do it and what could potentially be achieved by working with them. In particular, exchanges at the interface between the life sciences and the physical sciences and engineering are notoriously difficult. The precision, accuracy and problem-focused nature of the numerate disciplines contrasts with the inherent unpredictability of the life sciences and the more open-ended style of research. The Report puts a heavy emphasis on the clinical trials "pipeline" as the essential feature of translational medicine. However, it is clear that effective translation is a much wider enterprise than this, and that the key to it is the encouragement of interdisciplinary interaction in every aspect of biomedical science, and the generation of a culture of translation among basic researchers. There is a concern that the recommendation to establish a Translational Medicine Funding Board (TMFB), separate from the MRC's basic research, might actually decrease translational effort among the UK's excellent basic research community. In addition, if the TMFB is to achieve its full impact, it is essential that it should take its remit from the broad definition of "Medicine", ie the branch of health science and the sector of public life concerned with maintaining or restoring human health through the study, diagnosis and treatment of disease and injury (and not focus on drugs).

  15.  "Research Teams of the Future" (para 3.4), which is also one of the components of the NIH Roadmap for translational research, is aimed at increasing interdisciplinary and innovative working and removing barriers to such approaches. Undoubtedly in the UK there is an urgent need to train a new generation of scientist who can engage dynamically in interdisciplinary and innovative research. This is an essential prerequisite to deliver the strategy that the Report is recommending. However, the Report provides little insight into the deep problems that are obstacles to effective interdisciplinary collaboration and gives little guidance on how researchers who are expert in bridging disciplinary gaps can be trained. It is not clear how translational research of high quality will be delivered.

INNOVATION

  16.  SMEs are critical to the development of many of the most innovative products and services, and to the long term health of the medical engineering industry. The comments on SBRI are welcome. It is suggested that the Cambridge report on Small Business Innovation Research (SBIR)[6] is taken as an aspirational challenge on what could be achieved through a more imaginative approach to research funding, especially in support of the development of this vital sector of the medical engineering industry.

WANLESS REPORT

  17.   The Wanless Report[7] has been extremely important in helping to provide a consistent vision of the challenges facing healthcare in UK, and some of the potential solutions. Will the continuation and updating of this type of visioning activity be an explicit part of OSCHR's remit which all stakeholders can use and debate the implications of?

January 2007

GLOSSARY

DH	Department of Health
EPSRC	Engineering and Physical Sciences Research Council
ESRC	Economic and Social Research Council
MRC	Medical Research Council
NIH	National Institute of Health
OSCHR	Office for Strategic Coordination of Health Research
R&D	Research and Development
SBIR	Small Business Innovation Research
SMEs	Small and Medium Enterprises
TMFB	Translational Medicine Funding Board

5   http://www.nccrcd.nhs.uk/intetacatrain/Medically_and_Dentally-qualified_Academic_Staff_Report.pdf Back

6   Secrets Of The World's Largest Seed Capital Fund: "How the United States Government Uses its SBIR Programme and Procurement Budgets to Support Small Technology Firms": David Connell, Centre for Business Research, University of Cambridge. Back

7   http://www.hm-treasury.gov.uk/consultations_and_legislation/wanless/consult_wanless_final.cfm Back