1.  INTRODUCTION

  1.1  Cancer Research UK[17] is the world's largest independent organisation dedicated to cancer research, with an annual research spend of £300 million. Cancer Research UK funds research into all aspects of cancer from exploratory biology to clinical trials of novel and existing drugs as well as population-based studies and prevention research. We are the major non-commercial funder of research into drug innovation in Europe. Our funds are raised almost entirely through public donations. More than one million people regularly donate to Cancer Research UK.

  1.2  Cancer Research UK welcomes the findings of the Cooksey Review. We also congratulate Sir David and his team for the inclusive approach taken in conducting this review. As well as providing an extensive evidence submission, Cancer Research UK had the opportunity to meet with the Cooksey Review team on several occasions and we are pleased to see recommendations that reflect these positive discussions. In particular we were glad that the experience of Cancer Research Technology was of use in framing the proposals on improving innovation and knowledge transfer in the UK.

2.  GENERAL COMMENTS

  2.1  The UK has an enviable global reputation for medical research. The NHS provides a unique environment and opportunity to undertake world leading scientific, clinical and population based research. We welcome the commitment in the Cooksey Review to maintaining funding for health research across the UK and the recognition of the important role that this research plays in improving the health and wealth of the nation.

  2.2  In this respect we support the commitment to ring-fencing Department of Health Research and Development funding, to protect this from being redirected to other areas of NHS activity.

  2.3  A continued determination to work with funding partners, especially charitable funders, such as Cancer Research UK, will be crucial if these proposals are to work in practice. We are a little disappointed that specific assurances about this are not contained within the body of the report. As the major funder of academic clinical trials in the UK, and significant funders across the spectrum of health research, we believe that this involvement should be explicitly recognised above and beyond our role as partners within the UK Clinical Research Collaboration (UKCRC). Although the UKCRC does currently have significant influence over the strategy and coordination of clinical research in the UK, there is no guarantee that this will continue once the current workstreams (Regulation and Governance, Medical Careers, Infrastructure, NHS inducements for Research) come to completion. Cancer Research UK does not wish to have such a temporary working relationship with the Government's biomedical or health research activities.

3.  INSTITUTIONAL ARRANGEMENTS

  3.1  It is important when implementing the many laudable recommendations of this review that the institutional arrangements do not become an extra layer of debilitating bureaucracy. We believe that it is vital to maintain a degree of flexibility with a new system. We would also like further assurance of the political independence of the Office for Strategic Coordination of Health Research (OSCHR). While current close links between this body and the Treasury are clearly of benefit, it is important that this structure should continue to work regardless of future changes in the political landscape of the UK.

  3.2  There remain concerns that the total funding available to OSCHR will be significantly less than the current £1.3 billion.

4.  NON-PHARMACEUTICAL AND PUBLICLY FUNDED RESEARCH

  4.1  We note that this review has a strong focus on the development of new drugs with which to treat disease. It is important to remember that effective medicines represent the successful end-game of extensive and lengthy medical research.

  4.2  There are many areas of health research that do not necessarily lead to the development of new drugs, but focus on the psychosocial aspects of disease and non-drug related treatments, such as surgical trials and radiotherapy. Good outcomes for cancer patients are dependent on a multidisciplinary effort of which drugs are an important, but constituent, part. The new structures need to keep this in mind.

  4.3  It is also important that non-industrial anti-cancer drug trials are supported within the NHS just as vigorously as commercial trials. In cancer, this is essential to ensure that patients are not disadvantaged according to the type of cancer by which they are affected.

  4.4  Examples of this are the trials that Cancer Research UK funds through its Clinical Trials Advisory and Awards Committee (CTAAC). These trials often involve drugs which have already received marketing approval in the UK and which are being tested for use in different types of cancer or in an attempt to find more effective or efficient ways of using the drug in combination with others. Other similar trials look at the efficacy of combining different treatment modalities, such as surgery with chemotherapy. These trials would typically not be carried out by industry.

5.  UK-WIDE RESEARCH

  5.1  Similarly to the Medical Research Council (MRC), Cancer Research UK has UK-wide responsibilities in terms of supporting research. We therefore hope to see relationships with devolved administrations carried forward successfully. We are concerned that the Cooksey Review has not adequately addressed the question of how the proposed strategy will work on a UK-wide basis. This is particularly important for multi-centre trials which may be conducted at numerous sites across the UK.

  5.2  Research carried out by Cancer Research UK-funded researchers in Scotland, Wales and Northern Ireland has contributed significantly to the progress that we have seen in cancer treatment in recent years. This collaborative success must be supported and encouraged in the future.

  5.3  Cancer Research UK is keen that OSCHR takes a balanced view of nationwide investment. With over 85% of the MRC's spend focused on the south east of England and all the National Institute for Health Research (NIHR) Biomedical Centres also assigned within this region, it is important that the rest of the UK, and the devolved nations, are not neglected in terms of research spend. Our respective commitments to patients in general, and cancer patients in particular, mean that NHS R&D and Cancer Research UK should aspire to spread resources more evenly across the country. The establishment of a single research fund provides an opportunity to increase investment in some of the historically less well supported regions. This is a move which would serve to improve the country's long-term economic and medical interests.

6.  CLINICAL TRIALS IN THE UK

  6.1  It is not clear where accountability for clinical trials will lie under the proposed system. The MRC has an impressive legacy of funding and conducting clinical trials across the UK. This should be taken into consideration when drawing clearer distinctions between the funding roles of the MRC and the NIHR. This is particularly relevant for late phase clinical trials that appear to fall within the remit of both the MRC and NHS R&D funding streams (figure 7.4).

  6.2  We welcome recognition of concerns about the cost of conducting clinical trials in the UK (section 6.24) and note that these difficulties are not limited to those trials run by the pharmaceutical industry[18].

7.  CREATING A RESEARCH-FRIENDLY CULTURE IN THE NHS

  7.1  Given the significant role that charities play in funding research in the NHS, and our wealth of experience in understanding the costs involved (including the system of identifying the direct and indirect costs of research), we believe that any working group established should include membership from research charities. It is inevitable that the recommendations of this group will have a significant impact on the way research is funded in the NHS.

  7.2  While we welcome proposals to improve the implementation of best practice in health service management and delivery around the NHS, we would like to see the incentives that are being piloted recognise that health professionals in the NHS already have significant demands on their time. With this in mind it is important that provisions are made to build a supportive structure in the NHS within which to conduct research and a culture that promotes research activity.

  7.3  It is unfortunately also the experience of the National Cancer Research Network Clinical Studies Groups that trials are being held up because of uncertainty about NHS supportive funding for patients taking part in trials. To this end we welcome the recognition of a need for additional financial support from NHS Trusts. It is important that both Trusts and researchers know that NHS R&D money is guaranteed to follow the individual patient taking part in such research.

  7.4  We note with regret that one area where the UKCRC has so far made little progress is in providing incentivisation for research in the NHS. We strongly believe that the Healthcare Commission should include research performance as one of its criteria for measuring NHS Trusts' performance to enable OSCHR to achieve its full potential.

8.  SKILLS FOR HEALTH AND MEDICAL RESEARCH

  8.1  As a major funder of research fellowships and training across the UK, we believe that charities such as Cancer Research UK and the Wellcome Trust have an important role to play in identifying needs in terms of skills mix, experience and career structures across the whole spectrum of health research (paragraph 7.16). We therefore call for the inclusion of these funders in any future working group established to develop a strategy to address these needs. This will be vital to ensure that the UK develops a joined-up response to any gaps identified in this area.

  8.2  We would welcome clarification of what role it is anticipated that the UKCRC will play in coordinating the development and funding of MD-PhDs to eliminate skills gaps (paragraph 7.17) and further consideration of the appropriateness of this body to undertake such a role. Currently, the UKCRC does not have the remit to cover such training.

9.  THE ROLE OF THE UKCRC

  9.1  With the advent of the NIHR, its transition into a "real", rather than virtual, institute and the establishment of the NIHR as an executive body of the Department of Health, the Review rightly highlights the question of what role the UKCRC, and therefore charity representation, has to play under these proposed arrangements.

  9.2  The UKCRC has been highly successful in building on the achievements of the National Cancer Research Institute, which has seen enormous progress in increasing the number of cancer patients entering clinical trials. We are keen to see a clear role for this collaboration as a forum for advising on health research needs and on the interests of researchers across the UK in the future.

10.  TRANSLATIONAL RESEARCH

  10.1  The establishment of a Translational Research Board is an important recognition of the increased importance of translational research in the UK. We would greatly welcome more details of how this board is to work in practice.

  10.2  Through our own Clinical and Translational Research Committee, Cancer Research UK is a major funder of translational research in the UK. We believe that this may provide a good model for other types of research and a template for how a Translational Research Board might be established and run. We look forward to further engagement by OSCHR of research-funding partners, such as Cancer Research UK, in the establishment of this Board.

11.  TAKING FORWARD THE RESEARCH RECOMMENDATIONS OF THE NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

  11.1  We welcome recognition in the report of the need to address the financial challenges faced by the NHS in funding the increasing number of medicines coming onto the market. We also welcome the exploration of possible solutions to this problem.

  11.2  A clearer process for following up NICE's research recommendations is important. We believe that there is a need, collectively, to be able to turn negative NICE decisions into positive action. Such decisions are harmful to all stakeholders—patients, the Government, pharmaceutical companies and the cancer charities. The public is particularly disappointed when patients in England cannot access new treatments that are routinely available in the USA, Germany, France or even Scotland.

  11.3  We would therefore appreciate further discussion on how these recommendations will fit into the strategy-setting work of the OSCHR. We believe that the research community, Government and industry, need to work together to ensure that appropriate further research is conducted to identify possible specific applications for the drug, perhaps in defined patient groups.

  11.4  We have already seen examples where further clinical trials might be able to specify a sub-group of the patient population which would particularly benefit from a particular drug. This could then result in new applications to NICE for approval in a more limited market and therefore at reduced total cost to the NHS. One example of this is the trial that Cancer Research UK is currently undertaking with Avastin (bevacizumab) for the treatment of colorectal cancer. We are hopeful that this will provide additional evidence to demonstrate efficacy of this treatment when given over a shorter time-scale, to improve the cost-effectiveness of this drug for treating patients in the NHS.

January 2007

18   J Hearn, R Sullivan, The impact of the "Clinical Trials" directive on the cost and conduct of non-commercial cancer trials in the UK. Eur J Cancer(2006), doi:10.1016/j.ejca.2006.09.016 Back