Select Committee on Science and Technology Minutes of Evidence



MEMORANDUM SUBMITTED BY THE DEPARTMENT OF HEALTH

Introduction

Government Cancer Strategy

Cancer Research in the UK

Role of Government funders in Cancer Research

Role of NHS in supporting clinical trials in cancer

Improving support for cancer research

APPENDICES:

  1. Role of National Institute of Clinical Excellence
  2. DH/NHS R&D Support for Cancer Research
  3. Role of NHS in supporting clinical trials
  4. Cancer Gene Therapy

INTRODUCTION

  1.  Cancer is a major priority for this Government. The UK Health Departments lead on Cancer prevention and services. Each also makes a major investment in cancer research. We therefore welcome the opportunity to contribute to the Science and Technology Select Committee's inquiry concerning the organisation of cancer research. The detail of this response focuses on the Department of Health in England and those bodies operating UK-wide.

  2.  This document summarises government cancer strategy, highlights strengths in current UK cancer R&D, describes the role of government funders of R&D and arrangements for DH/NHS support of R&D and specific investment in cancer research, outlines the role of NHS and wider DH interests in supporting clinical trials in cancer, indicates steps being taken by the Department to enhance support for cancer R&D, and comments on the case for a National Cancer Institute in the UK.

GOVERNMENT CANCER STRATEGY

  3.  Cancer is responsible for 156,000 deaths in the UK each year, and over a quarter of a million people are diagnosed with cancer. Much of this is preventable—around one third of all cancer deaths in England are due to smoking, and poor diet is estimated to play a role in about one quarter of cancer deaths. Treatment of cancer is estimated to account for 6.3 per cent of NHS hospital expenditure in England (£1,479 million).[1]

  4.  The Government is committed to reducing the death rate from cancer among those aged under 75 by at least a fifth by 2010. To achieve this target, wide-ranging action is needed to improve cancer prevention, screening and treatment services. Professor Mike Richards, a leading cancer clinician, has been appointed as National Cancer Director to spearhead the improvements necessary to cancer services in this country and the Government is investing in cancer prevention and treatment to ensure all patients have prompt access to modern, high quality cancer services.

  5.  Improvements include establishing networks of cancer services across the country building on the principles set out in the Calman-Hine Report. These Networks encompass primary care, secondary care (Cancer Units), tertiary care (Cancer Centres) and relevant district health authorities. Networks typically cover populations of 1-2 million people.

  6.  Access to diagnosis and treatment is being improved through the Two Week Standard supported by the provision of targeted funds. Guidance on improving outcomes for breast, colorectal, lung, and gynaecological cancers has been published and targeted funding has been allocated to improve service delivery and in particular to establish specialist teams. Future Guidance will cover Upper Gastrointestinal cancers (oesophagus, stomach and pancreas), urological cancers (eg prostate and bladder cancers), haematological malignancies and head and neck cancers. The clinical and cost effectiveness of new chemotherapy treatments for cancer is being assessed by the National Institute for Clinical Excellence. Facilities for cancer diagnosis and treatment are being improved through the allocation of £100 million of government funds and £93 million from the lottery New Opportunities Fund. A cancer workforce review is currently in progress. We are training more clinical and medical oncologists than ever before. [2]

  7.  Action on prevention is being taken forward as part of the "Saving Lives: Our Healthier Nation" strategy and includes programmes on smoking cessation, increasing fruit and vegetable consumption, alcohol misuse strategy, enforcing regulations on exposure to asbestos, funding health education programmes and more vigorous screening programmes.

  8.  High quality research is a vital element in the government's cancer strategy, to support advances in cancer prevention and treatment, to improve service delivery and to provide the evidence base for effective prevention and screening strategies and national guidance to service providers.

  9.  The Department is concerned to ensure that research findings are rapidly disseminated into the NHS and used to improve patient care. The National Institute for Clinical Excellence, with a remit to develop clinical guidance based on the latest available evidence, will play a key role in getting research into practice. Annex 1 gives further details of the role of NICE. Reviews of the research evidence base are also being used to inform the development of National Guidance on Cancer Services. Other initiatives include The National Electronic Library for Health.

CANCER RESEARCH IN THE UK

  10.  The government is working with our partners to improve the co-ordination and support for cancer research. This should be seen in the context of the considerable strengths that the UK has in cancer research. We have:

    A world class research base with high quality epidemiological, basic and clinical research, and a number of centres of excellence linking research and patient care. Examples of world class clinical research include:

      Childhood Cancer—Major successes in leukaemia trials using intensive therapy have increased five year survival to over 70 per cent; collaboration between clinicians ensures over 90 per cent of children are entered into clinical trials of childhood cancers.

      Breast Cancer—Ongoing trial of chemoprevention (Tamoxifen) and studies to improve the use of mammography in screening (Breast Screening Frequency Trial and Breast Screening Age Trial).

      Colorectal Cancer—Ongoing trial of combination chemotherapy for patients with advanced cancer.

  These are all multi-centre trials involving thousands of patients and collaboration between clinicians, of major significance and of international interest. The UK also has expertise in psychosocial research and palliative care research in cancer.

  A unique test-bed in the NHS. The structure, organisation of and research funding for the NHS, enable the NHS to host, support, initiate and participate in basic, clinical and applied research offering a unique opportunity to all involved in cancer R&D for major multi-centre studies. The participation of NHS clinicians in research should allow the findings from research to be translated into patient care more quickly.

  A comprehensive cancer registration system and patient databases. The UK has one of the most comprehensive cancer registration systems in the world. This provides invaluable information for both epidemiological research and outcome studies.

  A collaborative ethos and evidence based culture among the clinical cancer community. Participation of clinicians and patients in clinical trials is crucial and has led, in the case of leukaemia, to improved outcomes for patients. We need to build on the collaborative ethos in the cancer clinical community and spread the achievements made in childhood cancer to other areas. Cancer clinicians recognise and value the importance of clinical trials and the need for evidence-based care.

  A co-ordinated approach to clinical trials—Mechanisms for coordination and collaboration in cancer research in the UK, particularly for trials, are well developed, and are greater than in many other areas of medical research. The UK Co-ordinating Committee on Cancer Research (UKCCCR) set up in 1970, brings together major funders and researchers to facilitate studies, particularly clinical trials. The Medical Research Council (MRC) Clinical Trials Office provides major support for cancer trials and the Cancer Research Campaign (CRC) supports a number of Trials Units. The National Screening Committee will ensure a more strategic approach to prospective screening trials. The newly established Cancer Research Funders Forum will help provide a more strategic approach to cancer R&D, including trials.

  Good networks among clinicians in specific areas of cancer research, for example the UK Children's Cancer Study Group (UKCCSG), which co-ordinates and implements clinical trials for all the solid tumours of childhood. It also maintains a register of all cases of childhood cancer (including leukaemia) treated in any of the 22 UKCCSG Centres. The Cancer Family Study Group co-ordinates clinical research on cancer genetics. A significant number of patients in the European Organisation for Research and Treatment of Cancer (EORTC) are UK patients.

  Substantial support for research. The government, charities and industry invest over £300 million a year in work directly on cancer. Cancer research benefits substantially from the cancer charities. The government also invests in basic science which will improve our understanding of the mechanisms underlying cancer.

  Major scientific opportunities emerging from the human genome project which will impact on cancer prevention and care. The UK are world leaders in genetic epidemiology. In the next 10 years we will be making enormous strides into the interaction between genetics and the environmental factors causing cancer and as a result will be developing new approaches in the prevention and treatment of cancer. The UK is already in the forefront of gene therapy trials in cancer.

  A continuing commitment from government to invest in high quality basic, clinical and applied research to secure improvements in cancer outcomes. In particular, the Government is investing a significant proportion of the extra £90 million made available to the MRC (following the 1998 Comprehensive Spending Review) on the post human genome challenge, to improve our understanding of the genetic basis of cancer and other diseases. The government is also committing £15 million through the MRC to a new centre at Cambridge translating basic research into clinical applications, in collaboration with the CRC, and is using resources from the science budget to invest in new infrastructure to support cancer research. Through the Department of Health's R&D budget, the government is spending over £60 million a year to support the NHS' involvement in cancer research, which underpins the work of research councils and charities, and continues to invest in directly commissioned research.

COMPARISONS WITH OTHER COUNTRIES

  11.  The UK compares favourably with other EU countries in relation to cancer R&D activity and quality. While US cancer R&D expenditure is substantially higher, their budget includes service support and treatment costs that in the UK are picked up through other funding mechanisms (principally the NHS). The apparent costs of conducting clinical research in the UK are almost certainly much lower as a result of the access to patients provided by the NHS. The Cancer Research Funders Forum is developing a database of cancer R&D, modelled on the National Cancer Institute database, which will facilitate more helpful comparisons.

ROLE OF GOVERNMENT FUNDERS IN CANCER RESEARCH

  12.  The Government is making a substantial contribution, currently over £110 million[3] per annum, to the funding and conduct of Cancer R&D. Government support for cancer research is provided through funding for the science base (which includes the Funding Councils funded by the Department for Education and Employment as well as the research councils funded by the Department of Trade and Industry) and through departmental R&D programmes.

  13.  Science base funding from the Department of Trade and Industry for the Medical Research Council (MRC) is the main route through which the government provides support for research into the basis of and treatment of disease, including cancer. The MRC currently spend £28.5 million annually on research targeted at cancer and £50-70 million on basic research directly relevant to cancer. Other MRC investment in basic science is also relevant to cancer, as it is through basic research that major advances in the treatment of cancer are likely to come. MRC is playing a key role in translational research, which aims to develop more rapidly clinical applications of basic scientific developments.

  14.  The MRC/UK Health Departments Concordat ensures close working at a strategic and operational level between these funders and also guarantees NHS support for MRC funded clinical trials taking place in the NHS.

  15.  The Department of Health support for research complements the MRC's investment. DH/NHS R&D provides R&D support for NHS providers, which underpins and extends the work of the Research Councils and charities, as well as funding NHS provider-led research (£360 million per annum in total). NHS R&D also invests in directly commissioned research to provide the evidence base for effective health care interventions and services through national and regional NHS R&D programmes (70 million per annum). The Department has a Policy Research Programme to provide the evidence base for public health, health services and social care policies (about £30 million per annum). In addition the Department supports other ad hoc projects in public health and R&D activity in a number of non-Departmental bodies, (about£50 million per annum). The total DH/NHS R&D support for cancer research from these budgets is currently over £75 million per annum; over £60 million of this is R&D support for NHS providers, the largest commitment to a single disease area from this budget.

  16.  Priorities for NHS directly commissioned R&D programmes are identified through consultation with those using, delivering and managing services. They take account of the burden of disease, potential benefits, and government objectives and priorities, as well as the responsibilities and work of other findings. Horizon Scanning is also used to identify and scope issues the NHS needs to address and the contribution research might make. The NHS R&D Health Technology Assessment Programme in particular is taking account of the requirements of the National Institute of Clinical Excellence in its priority setting and has already responded to the cancer related topics in its work programme. DH priorities for cancer R&D include work to review the evidence to underpin National Guidance on Cancer Services.

  17.  Within the current portfolio of DH and NHS directly commissioned research, we have:

    —  a programme of research and reviews on cancer screening, including breast, colorectal and cervical, prostate, ovarian cancer and melanoma;

    —  projects working with industry developing endoscopic and imaging techniques for cancer diagnosis;

    —  health technology assessments of interventions for cancer screening, diagnosis and treatment and for a range of cancer sites;

    —  a programme of work on the delivery of health services for cancer patients to help improve the organisation of services, help reduce variations in care and investigate delays in presentation.

  Further details of DH support for cancer research are set out in Annex 2.

  18.  The Department is currently revising arrangements for NHS R&D funding into two new funding streams—NHS Support for Science and NHS Priorities and Needs. The new arrangements will be announced shortly. They will help improve the identification and co-ordination of NHS R&D support for cancer and the implementation of DH/NHS cancer R&D priorities.

SUPPORTING CLINICAL TRIALS IN CANCER

Role of the NHS

  19.  The NHS supports clinical trials of cancer treatment by leading and participating in trials and by providing the associated service and treatment costs. In addition some trials are directly commissioned by the NHS R&D Programme. The Department is working to improve the infrastructure for cancer clinical trials in the UK and to promote participation of both professionals and patients in cancer trials.

  20.  The NHS is providing major support for cancer clinical trials through service support (provided by NHS R&D) and treatment costs. These costs often exceed research costs.

  21.  To maximise benefits for patients, the NHS needs good clinical cost effectiveness data on new interventions, as well as clinical trials of efficacy, and has taken the lead, through the Health Technology Assessment Programme, in setting up appropriate studies in cancer. The Department has also been proactive in setting up cancer screening trials.

  22.  The introduction of the NHS R&D Levy, and associated clarification of policy on the service and treatment costs to be met by the NHS for non-commercially funded R&D (in HSG(97)32), has ameliorated many of the problems experienced previously in accessing NHS support for clinical trials.

  23.  To facilitate NHS professionals' capacity to participate in cancer trials, the Department is developing a proposal to improve the infrastructural support available for cancer clinical trials taking place in the NHS and linking it more closely to the developing cancer service networks. The NHS Clinical Trials Director has also undertaken work to define needs for trial support units and harmonise different funders input.

  24.  Commercial investment in clinical trials of new cancer drugs is essential to improve outcomes for patients. The Department is keen to maintain the UK as a place to do clinical trials for new cancer drugs. We are working with industry to develop a framework to improve NHS-industry interaction in clinical trials and other research.

  Further details of the role the NHS plays in supporting clinical trials are set out in Annex 3.

Wider DH role

  25.  In its wider role as sponsor of the pharmaceutical and healthcare industries, the Department is also concerned to ensure that the UK continues to maintain an environment conducive to commercial R&D; because of the benefits this brings to the NHS and patients, in helping to keep the UK at the forefront of medical advance, and the stimulus it provides to all those involved in cancer R&D and/or treatment to improve services for patients. The UK based pharmaceutical industry is among the world's best (five out of the world top 20 medicines were developed, or discovered in British laboratories) and the UK pharmaceutical industry's overall investment in R&D is over £2.5 billion a year. The government is determined to ensure the UK remains an attractive location for the pharmaceutical industry, especially in relation to investment in R&D. A new Task Force will shortly be formally announced which will bring together industry leaders and government Ministers to identify action needed to ensure the continued global competitiveness of the UK based industry—which, above all, means to ensure its continued capacity to invest in R&D to innovate and develop effective new medicines.

  26.  Clinical centres in the UK have been particularly successful in attracting support for Phase I and II clinical trials in gene therapy from commercial companies. The Gene Therapy Advisory Committee set up by DH has played an important role in these developments. (See Annex 4 on Cancer Gene Therapy.)

  27.  The Department also has statutory responsibilities relevant to clinical trials and new medicines. Under UK legislation the Medicines Control Agency (MCA) is responsible for the approval and monitoring of clinical trials (on medicines) undertaken on patients in the UK. In the past five years the MCA has assessed all clinical trials notifications within the statutory deadline of 63 days. In 1998-99, 95 per cent of notifications were assessed within the 35 day period. (The remaining 5 per cent were extended for the applicant to provide further information.)

  28.  The MCA recognises the need for life-saving medicines to be made available to patients as quickly as possible, and is acknowledged as one of the fastest medicine licensing authorities in the world. The Agency is currently achieving an average of 34 working days for assessing new active substances.

  29.  All clinical trials in the UK must be approved by a Research Ethics Committee before they may begin. It is the role of the Ethics Committee to consider the ethical issues in the proposed trials, including the validity of the research, the welfare and dignity of any patient enrolled in the trial, the arrangements for obtaining consent and the information provided as the basis for that consent.

  30.  A draft European directive on clinical trials is currently under negotiation. The UK's aim is to ensure that the system developed will protect the health of clinical trial participants whilst allowing rapid development of pharmaceutical products.

IMPROVING SUPPORT FOR CANCER R&D

  31.  Although UK Cancer R&D has many strengths, and benefits from substantial Government as well as charity and commercial R&D funding, the Department is not complacent; there is scope for improvements and we are actively working with our partners, the MRC and charities and industry, to deliver them.

  32.   Working to ensure a more strategic approach across cancer research funders. Last Summer, the Prime Minister convened a Cancer Summit at Downing Street and as a direct result we have established a Cancer Research Funders Forum to consider strategic issues across the whole of cancer research, identify the obstacles to progress, and forge collaborative approaches to tackle them. The Forum comprises the major cancer research funders in the UK including the Medical Research Council, the Departments of Health, the Imperial Cancer Research Fund and the Cancer Research Campaign. It will provide an opportunity for greater strategic co-ordination between funders than is currently possible through the UKCCCR.

  33.   Prostate cancer was one of the first issues to be addressed by the Cancer Research Funders Forum. The major cancer research funders have expressed their commitment to increased support for high quality prostate cancer research, and have initiated an expert review to enable them to make rapid progress. The review is being co-ordinated by the Medical Research Council, chaired by Dr Peter Rigby, and aims to complete its work and report within months.

  34.  As a key component of this concerted programme of action, the Department of Health has made a commitment to provide an additional £1 million for high quality research on prostate cancer research in the coming financial year. This will substantially increase the national investment in prostate cancer research. The focus of this research will be to improve detection, prevention and treatment of prostate cancer.

  35.   Enhancing the infrastructure to support clinical trials. Reference has already been made to developing proposals to improve the infrastructure for cancer clinical trials taking place in the NHS, which would support both large trials and early phase translational studies. Detailed proposals are being worked up and will be pursued through the Cancer Research Funders Forum.

  36.   Identifying targeted research priorities for DH/NHS investment in cancer R&D. As part of a recent review of NHS R&D funding arrangements, expert review groups were set up to consider priorities for NHS R&D in relation to key government priority areas including cancer, coronary heart disease and mental health. The Cancer Topic Review Group's report (which will be available shortly) will be used to inform future NHS R&D strategy in cancer, which is being developed with advice from Professor Mike Richards, National Cancer Director, Professor Peter Selby (Imperial Cancer Research Fund) and Professor David Kerr (Birmingham University).

  37.   Supporting public health research. The Department is also investing in public health research, for example on smoking, nutrition and health inequalities, which will inform cancer prevention. The Health Development Agency will also be looking at the evidence base for health promotion strategies and will identify gaps for further research investment.

  38.   Investing in the future. Major advances in understanding the basis of cancer and treating cancer and other diseases are likely to come from exploiting the possibilities arising as a result of the human genome project. Government is making a major investment in this area. In particular the Department is working with the Medical Research Council and Wellcome to create a national cohort database of linked genetic and health data to elucidate gene/environment interactions.

A UK NATIONAL CANCER INSTITUTE

  39.  There have been calls for the establishment of a National Cancer Institute (NCI) in the UK, along the lines of the NCI in the United States. The US NCI has a budget of $3,000 million per annum and supports basic biomedical and clinical research and a number of centres across the US. It is funded by the US government through the National Institutes for Health (NIH).

  40.  Within the UK context it is not clear what the added value of an NCI would be. While there is no doubt that successful basic research requires a critical mass of high calibre scientists, clinical research needs to map on to the pattern of care, which in the UK follows a more distributed model. There are already a number of UK centres of excellence in cancer research combining research and patient care, eg The Royal Marsden/Institute of Cancer Research, the Christie, as well as centres of excellence in more basic research.

  41.  Concentrating research activity (and some arguments for an NCI have suggested concentrating treatment as well) will not help improve access for patients to the most modern cancer care available and nor help reduce inequalities in care. Indeed, it could disenfranchise some patients and clinicians by monopolising resources. An NCI could become an exclusive organisation; it will be preferable to build more inclusive research networks.

  42.  It should be possible to achieve the objectives of an NCI, which might include improved collaboration between researchers, co-ordination of clinical research, better translation of basic research into clinical applications, more synergy between basic research efforts, a more strategic approach to cancer R&D investment, without necessarily creating a new institution. Improving the links between existing centres and creating a national network would probably be more effective in the UK setting.

CONCLUSION

  43.  Current developments in science present exciting opportunities for new approaches to prevention and treatment of disease, especially cancer. It is vital that advances in cancer science are fed into cancer care to maximise benefits for patients. The Department is working with its partners in government, charities, universities and industry to create a productive research environment and deliver an effective research investment strategy.



Annex 1

ROLE OF THE NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE (NICE) IN RELATION TO CANCER TREATMENT

  NICE's key role is to bring together the research evidence on clinical and cost effectiveness and to use it as the basis for authoritative guidance to help front-line clinicians and commissioners. NICE will be issuing guidance in two main areas, both relevant to cancer treatment:

    —  Appraisals of individual clinical interventions (drugs, medical devices, diagnostics, other therapeutic procedures). Typically, an appraisal will result in clear recommendations on whether, taking the broad balance of clinical benefits and costs, the procedure represents a good use of NHS resources—either in general or for particular patient subgroups. On occasion, an appraisal may conclude that a new intervention is promising but "not proven", and may indicate the areas of remaining uncertainty in which more research is required. NICE will be carrying out some 30-50 appraisals each year, focussing on interventions which have the greatest potential impact on patient care;

    —  Clinical guidelines, packages of guidance on best clinical practice for particular patient groups or conditions. NICE is expected to issue some 12-15 major clinical guidelines each year, together with related audit methodologies, to enable clinicians to audit their continuing practice against national standards. In addition, NICE will be developing Referral protocols, which can be regarded as partial clinical guidelines to help GPs and others determine when patients would benefit from referral to specialist care.

  NICE's forward work programme is determined by ministers after consultation with the NHS, patient and professional bodies, and with NICE itself. The initial work programme, covering the remainder of 1999-2000 and the first part of 2000-01, was announced on 4 November 1999. It included:

    —  appraisal of the use of the taxanes in ovarian and breast cancer;

    —  appraisal of a new approach ("liquid based cytology") for preparing slides for cervical cancer screening;

    —  clinical guidelines for urological, head and neck, dermatological and haematological cancers.

  Additions to the work programme will be announced from time to time. In particular, the National Cancer Director, Professor Mike Richards, has been asked to advise urgently on a number of further anti-cancer drugs which might benefit from appraisal by NICE, and an announcement will be made shortly.



Annex 2

DEPARTMENT OF HEALTH/NHS SUPPORT FOR CANCER R&D

  1.  The Government supports health research in the UK through a number of routes:

    —  the Department for Education and Employment provides research infrastructure funding for universities via the Higher Education Funding Councils;

    —  the Office of Science and Technology at the Department of Trade and Industry provides funding to Research Councils, particularly the Medical Research Council, to meet the additional costs of research projects and undergraduate training;

    —  the Department of Health (England) provides funding:

      —  through NHS R&D Funding which supports projects funded by other, non-commercial R&D funders (including charities) carried out in the NHS, and also specific health and social care projects which meet identified research needs of the Department and the NHS;

      —  through its commissioned Policy Research Programme (PRP); and

      —  through ad hoc project funding and through support for non-departmental public bodies;

    —  other UK Health Departments also invest in health research.

NHS RESEARCH AND DEVELOPMENT FUNDING

  2.  NHS Research and Development Funding aims to improve the knowledge base for health services. NHS Research and Development funding has two distinct budgets:

    —  R&D Support for NHS Providers: this funding goes directly to NHS providers including primary care practitioners as well as NHS Trusts; and

    —  NHS R&D Programmes: this funding is used to commission research directly and to support a number of research related activities.

  (These budgets are currently being realigned into two new budgets—NHS Support for Science and NHS Priorities and Needs.)

R&D SUPPORT FOR NHS PROVIDERS

  3.  Through this route the NHS provides support for research funded by the Research Councils and Charities which takes place in the NHS. Such research generates service costs which are met through this budget. This budget also supports research undertaken by NHS providers on their own account. Most of the current £360 million per annum budget was allocated from April 1998 in the form of three-year funding agreements with NHS providers. A small budget is available for allocation in the intervening years.

  Over £60 million per annum of this budget is currently used to support cancer R&D, the largest commitment to a single disease area in this budget. This includes £17 million per annum at the Royal Marsden, £10 million per annum at the Hammersmith, as well as support for the Christie Hospital in Manchester.

  Major cancer trials supported include taxol and breast cancer, flexible sigmoidoscopy screening for bowel cancer and a number of major trials funded by the Cancer Research Campaign.

NHS R&D PROGRAMMES

  4.  The budget for this programme is currently around £70 million. This includes three main national programmes: Health Technology Assessment, Service Delivery and Organisation, and New and Emerging Aspects of Technology, as well as a number of time-limited programmes on a range of conditions, including a Cancer programme. Research is commissioned directly (typically from universities) by NHS R&D on behalf of the NHS as a whole. This budget also supports an underpinning methodology programme, the UK Cochrane Centre and the NHS Centre for Reviews and Dissemination, research capacity building, and Regional NHS R&D. Current annual spend on directly commissioned cancer research projects in the NHS R&D programmes is about £4 million.

HEALTH TECHNOLOGY ASSESSMENT (HTA) PROGRAMME

  5.  The HTA Programme covers all interventions, new and existing including the use of devices, equipment, drugs, procedures and care across the whole spectrum of medical, nursing and health practice. The programme is managed by the National Co-ordinating Centre for HTA, which establishes priorities after widespread consultation with a range of users, professionals and managers in the NHS. The HTA programme has commissioned a number of research reviews and primary research projects on cancer, covering screening, prevention, breast, gastrointestinal, haematological, gynaecological, urological and childhood cancer.

SERVICE DELIVERY AND ORGANISATION (SDO) PROGRAMME

  6.  The Service Delivery Organisation programme will commission research to help improve the organisation and delivery of health services. Prioritising and commissioning research under this programme is to be managed by the London School of Hygiene and Tropical Medicine. It is anticipated that programme spend will build steadily to around £5 million per annum by 2004-05. Consultation and prioritisation processes are still being developed.

NEW AND EMERGING APPLICATIONS OF TECHNOLOGY (NEAT) PROGRAMME

  7.  This new programme aims to promote and support, through applied research, the use of new or merging technologies (in the widest sense) to develop health care products and interventions to enhance the quality, efficiency and effectiveness of health and social care. NEAT has an anticipated budget of £5 million over five years.

CANCER R&D PROGRAMME

  8.  The programme's priority areas were set by an Advisory Group of the NHS Central R&D Committee in 1994. The priorities were wide-ranging encompassing for example, primary prevention, the natural history of early disease and other issues relevant to the organisation and delivery of services. The R&D priority setting process coincided with the development of the Calman/Hine report on cancer services. There was cross-representation of experts between the advisory groups for these initiatives to ensure the closest match between R&D priorities and service needs for knowledge. The programme has commissioned a total of 48 projects, which will cost in the region of £5.3 million spread over six years, to meet these priorities. Many projects have now finished and relevant findings are being directly fed into the National Cancer Group's work on developing clinical guidelines for specific tumour sites.

RESEARCH FUNDED BY NHS REGIONAL R&D

  9.  Regional R&D budgets are intended to allow Regions to identify and support local priorities and build research capacity. Many of the projects, individuals, and initiatives funded directly through the eight regions involve cancer. The total annual direct spend on cancer research through this route is about £2.5 million.

THE UK COCHRANE CENTRE AND THE CENTRE FOR REVIEWS AND DISSEMINATION

  10.  The United Kingdom Cochrane Centre (established in October 1992) facilitates and co-ordinates reviews of research, primarily in the specialised area of randomised controlled trials of health care. The Centre for Reviews and Dissemination at York University (established in December 1993) commissions and supports experts to undertake specific systematic research reviews in areas of priority to the NHS. These two centres have each developed and applied rigorous systematic approaches. In so doing, they have offered models that others can use or adapt to suit different fields of reviewing. Within the international Cochrane Collaboration there are a number of Cochrane Review Groups covering cancer, including breast, colorectal, lung, ear nose and throat, gynaecological, prostatic and urological and upper gastrointestinal and pancreatic disease. The Centre for Reviews and Dissemination has been involved in producing reviews on screening for ovarian cancer and on improving the outcomes for breast and colorectal cancers. These last two reviews informed the work on National Cancer Guidance.

POLICY RESEARCH PROGRAMME (PRP)

  11.  The purpose of the Department of Health's PRP is to provide a knowledge base for health services policy, social services policy, and central policies directed at the health of the population as a whole. Its priorities are determined by the following criteria:

    —  Ministerial priority and relevance to the goals, aims and objectives of the Department of Health;

    —  size and importance of the problem to be addressed in terms of actual or potential burden of disease or social condition;

    —  well-defined plans for introducing research results into current policy activity or the formulation of future policy;

    —  timeliness;

    —  feasibility of research;

    —  likely return on the investment in research.

  12.  The PRP budget is £30 million per annum of which about £2.1 million per annum is currently spent on cancer research in the PRP. This includes work on cancer screening, childhood cancer, skin cancer and reviews of the evidence base for service guidance. Areas of cancer research funded by the PRP are described below. There are a number of other research initiatives being developed, including those on smoking, nutrition, and health inequalities, which also have implications for cancer.

  13.   Cancer Screening. The Department provides core funding for the Cancer Screening Evaluation Unit (CSEU) which works on the evaluation of screening, primary prevention studies and analyses of clinical trials. Current DH support includes monitoring of the NHS Breast Screening programme, methods for assessing the contribution of screening to the decline in breast cancer mortality in England and Wales since 1988, evaluating the breast screening pilot programme in women aged 64 to 69 years and the NHS cervical screening programme.

  14.  Other screening studies supported by the PRP include an evaluation of the colorectal cancer screening pilot project (by a collaborative team from the University of Edinburgh) which is being set up on two sites, one in England and one in Scotland, which is due to start in Spring 2000.

  15.  Joint support (with the MRC, CRC and ICRF) is also being provided for clinical trials on breast cancer screening, looking at the effect of age and screening frequency on breast cancer mortality of annual screening from age 40. This work will help to optimise the effectiveness of the National Breast Screening Programme in reducing breast cancer mortality.

  16.   START trial. This was developed in response to the serious problems experienced by a number of women who underwent radiotherapy. The START trial (standardisation of breast radiotherapy) is run by the Institute of Cancer Research.

  17.   Service Delivery and User Involvement. The PRP is funding the production of the research evidence for the national cancer guidance documents intended to help health authorities and NHS trusts improve cancer services. Current activity focuses on urological, head and neck, haematological and skin cancers. There is also a project on best practice for user involvement in cancer services and an evaluation of the Cancer Services Collaboratives, which aim to improve the delivery of care for patients with suspected or diagnosed cancer.

  18.   Childhood cancer. DH also core funds the Childhood Cancer Research Group (CCRG) which has played a major role in gathering and analysing data on causes, incidence and survival. It runs the national registry of childhood tumours and carries out important epidemiological research on genetic and environmental factors which may influence the incidence of such cancers. The PRP is also funding analyses of vitamin K and childhood cancer.

  19.   Skin cancer. The PRP is funding an initiative aimed at reducing the incidence of skin cancer, including projects on how ultraviolet radiation induces skin cancer, how the potentially harmful health effects of sunbeds are caused, and on gaining a better understanding of the public's knowledge, attitudes and behaviours in relation to sun and tanning.

  20.  The PRP also funds a MedLink programme to develop medical devices. Government funding is matched by industry. Current projects include devices which will improve breast imaging.

OTHER DEPARTMENT OF HEALTH FUNDED R&D ON CANCER

  21.  The Department funds some research on cancer as part of its work to investigate and provide expert advice on the health effects of radiation and chemicals in the environment. The Department's expert committees advise on the carcinogenic risks associated with chemicals and radiation and encourage further research in areas of concern. The areas currently funded are:

    —  The health risks of radiation, including cancer, funded from the Radiological Protection Research Programme budget (current spend for 1999-2000 is £1.596 million);

    —  The Small Area Health Statistics Unit (SAHSU) which investigates the association between health effects, including cancer, and point sources of chemical and radiation exposure. SAHSU is funded by six Government Departments including DH (DH current spend for 1999-2000 is £235,000);

    —  Chemicals in the environment: a number of relevant individual projects have been commissioned as part of wider research programmes on the health effects of chemicals or air pollution, or following recommendations from expert committees for follow-up on specific issues eg on the possible association between consumption of alcohol and breast cancer. Current funding of ad hoc projects on cancer is approximately £400,000 in total.

  22.  The National Radiological Protection Board (NRPB), which is a Department of Health funded public body, undertakes a substantial programme of research on cancer risk after exposure to internal and external ionising radiations. The programme includes studies of cancer rates in UK Nuclear Workers and UK Nuclear Test Veterans as well as data analysis and modelling on childhood cancer around UK nuclear installations. Experimental studies are also undertaken on the mechanisms of chromosome damage, the role of that damage in the development of cancer and the categories of heritable genes that can influence cancer risk after radiation. Research is also undertaken on non-ionising radiation, in response to concerns that exposure to electromagnetic fields and radiations might influence the rate of cancer development. NRPB staff have supported the National Childhood Cancer Study in relation to exposure assessments for ELF magnetic fields. They are also working on wavelength dependent cytogenic/biochemical changes that might influence skin cancer development.

PUBLIC HEALTH DEVELOPMENT FUND—ACTIVITIES RELEVANT TO CANCER R&D

  23.  As part of the £96 million Public Health Development fund, which has been set up principally to support new approaches to reduce health inequalities and tackle priority areas in "Saving lives: Our Healthier Nation", a number of schemes have been approved which are relevant to Cancer R&D:

  National Cancer Intelligence Unit: Initial funding will scope the remit for a Unit which could collate information about all aspects of cancer, so as to assess implications for policy and facilitate the monitoring and evaluation of policy. Such a Unit could help co-ordinate the regional cancer registries.

  Office for National Statistics and cancer registries have been funded to examine how improvements in the timeliness of information provided about the incidence of cancer and survival can be provided.

  Geographical Inequalities.   Differences in cancer survival between the UK, other European countries and the USA are large, persistent and unexplained. An international group has been set up by the London School of Hygiene and Tropical Medicine to try and explain these and DH is funding the first phase of this project.

  Socioeconomic inequalities.   The Small Area Health Statistics Unit has been funded to explore the reasons why mortality from cancer and other diseases is worse in deprived and thus inform work on health impact assessments.

DH/NHS R&D EXPENDITURE ON CANCER RESEARCH

  24.  The expenditure on Cancer R&D by DH/NHS R&D for 1998-99 is as follows:
£million
Policy Research Programme2.1
R&D Support for NHS Providers63.0
NHS R&D Programmes4.0
Other DH R&D[4] 6.3
Total75.4



Annex 3

ROLE OF THE NHS IN SUPPORTING CANCER TRIALS

  The NHS supports clinical trials of cancer treatment by hosting and initiating trials and by providing the associated service and treatment costs. In addition some trials are directly commissioned by the Department of Health on behalf of the NHS. The Department and the NHS are working with their R&D partners in the universities, research councils, charities and industry to improve the infrastructure for cancer clinical trials in the UK and to promote participation of both professionals and patients in cancer trials.

1.  NHS FUNDING FOR SERVICE AND TREATMENT COSTS OF TRIALS

  The general policy on the NHS responsibilities for meeting patient care costs associated with R&D in the NHS, including clinical trials, is set out in Health Service Guidance, HSG(97)/32. The main arrangements, which differ depending on whether the trial is non-commercially or commercially funded, are set out below.

1.1  Providing NHS costs for trials whose research costs are met by external non-commercial funders

  The NHS meets the support costs for non-commercial research which has been sponsored by eligible external funders. This support applies to research sponsored by Research Councils and the major charities. In return, these organisations are expected (under a concordats with Research Councils and a partnership agreement with charities) to consider the costs falling to the NHS, as well as the costs falling to them as research funders, in assessing value for money and deciding which research proposals to fund. NHS support costs cover service support and treatment costs.

  Service Support. These costs are the additional patient care costs associated with the research, which would end once the R&D activity in question had stopped, even if the same patient care service continued to be provided. This might cover things like extra blood tests, extra in-patient days, and extra nursing attention. The service support costs of research are met from NHS R&D budgets.

  Treatment Costs. Treatment costs are those which would continue if the experimental treatment came to be used in routine practice. Examples of treatment costs are the cost of a licensed drug, a diagnostic or therapeutic device, a surgical procedure or method of counselling or organising services. Treatment costs of trials are usually funded from normal NHS patient care funding mechanisms. However, the NHS Executive realises that certain trial treatments are very expensive, and unevenly distributed around the country. Meeting these costs in full from service budgets could penalise other patients in participating centres. In such cases, the NHS Executive is able to make a subvention payment for excess treatment costs. For example, a subvention was made to assist hospitals which participated in the recent MRC sponsored study of screening for cancer of the colon. About 40 per cent of the current subvention budget is spent on cancer trials. In some cases pharmaceutical companies provide contributions towards Phase IV drug trials or other studies sponsored appropriately by non-commercial funders, generally through free supplies or supplies at reduced cost.

1.2  Commercially funded clinical trials

  Where R&D is primarily for commercial purposes, (eg studies of a new drug prior to licensing), NHS Trusts are expected to recover the full cost from the commercial company on whose behalf it is carried out. This includes both service support and treatment costs. However, research is not automatically considered "commercial" simply because there is industrial funding. Commercial companies also support non-commercial work jointly with NHS bodies or non-NHS research funders. If the work is primarily for the public benefit, rather than the direct commercial benefit of the company concerned, it may be considered non-commercial and the arrangements described above may be applicable.

2.  COMMISSIONING OF CLINICAL TRIALS

  The Department of Health directly commissions clinical trials through the NHS R&D Programme and, occasionally, through other centrally funded programmes (described in the previous Annex). These trials are principally concerned with examining the clinical and cost effectiveness of interventions, for example the NHS Health Technology Assessment Programme has commissioned a study into effectiveness of a naturally occurring, biologically active substance (interferon) for the treatment of cancer of the kidney. The Department operates mainly in commissioning mode—where the need for research is identified first, and then researchers are invited to submit a protocol to address identified questions. The Department and the NHS meet all the costs of these trials. Where trials are commissioned by Health Authorities or by NHS providers, the NHS also meets all the costs.

3.  ACADEMIC INFRASTRUCTURE FOR CLINICAL TRIALS

  The NHS Clinical Trials Advisor has made an inventory of all clinical trials support units in the country. About 40 per cent of the existing trials units identified are involved in cancer research, with support coming from the MRC, Cancer Charities (especially the Cancer Research Campaign) and NHS R&D funding. A meeting was held in January 2000 to discuss a national strategy for the support of clinical trials in England and a discussion document is being prepared. As part of the recent review of the NHS R&D Levy, (the Clarke review), the Cancer Topic Working Group identified the need for improvements in the infrastructure for cancer trials as its highest priority. A proposal is currently being drawn up to enhance the service support and R&D resources available in the NHS for cancer R&D which will map onto cancer service networks.

4.  INCREASING PARTICIPATION IN CLINICAL TRIALS

  There are considerable benefits for patient care of high quality clinical trials. Research has also shown that patients who participate in trials, tend to do better on average than non-trial controls, even where the experimental treatment turns out to be no better than control treatment. The evidence suggests that this "trial effect" is mediated through careful adherence to the protocol for all patients (including controls) in clinical trials.

  While recruitment to trials in some areas is particularly good, eg in childhood cancer over 90 per cent of patients are entered into trials, in many others it is poor. A number of projects in the NHS National Cancer R&D programme have examined the factors affecting participation in cancer clinical trials. The findings from completed projects fed into the January 2000 conference mentioned above.

  The NHS R&D programme has also commissioned research into the ethics of clinical trials—including cancer trials. This work has emphasised the importance of very careful counselling when people are offered entry into clinical trials; the nature and purpose of trials is often misunderstood.

IMPROVING INFORMATION ABOUT CLINICAL TRIALS IN THE NHS

  5.  Details of research projects undertaken in the NHS are currently made available on the National Research Register, funded by the Department of Health. To improve the information on clinical trials, the Department and the NHS are currently working in collaboration with the MRC and charities to develop a national register of all publicly and charitably funded clinical trials.



Annex 4

CANCER GENE THERAPY

Cancer gene therapy in the UK

  Gene therapy, simply defined, is the introduction of beneficial genes into the cells of patients. The initial goals of gene therapists were to cure genetic disorders but the potential for developing treatments for cancer was quickly realised. More gene therapy studies take place in the UK than in any other European Country (placing the UK second only to the USA and accounting for more than 10 per cent of all trials globally). Thirty-three cancer gene therapy trials have been approved in the UK accounting for 80 per cent of all UK gene therapy trials. Several hundred UK patients have already participated in cancer gene therapy trials. Target cancers include breast, ovarian, cervical and liver cancer as well as lymphoma, melanoma and glioma (brain tumours).

Gene therapy success

  In October 1999 cancer researchers in the US reported the successful use of gene therapy to activate the human immune system against metastatic prostate cancer. Here in the UK, several patients enrolled into a number of different studies have shown signs of apparent benefit (such as disease regression or stable disease). Such results have resulted in growing optimism that gene therapy is finally coming of age and that this approach may add new treatment approaches to enable doctors to eliminate cancer cells that are not destroyed by conventional therapies (surgery, radiation or chemotherapy).

Oversight/funding of Gene Therapy

  The UK, with its scheme of national review of gene therapy by the Gene Therapy Advisory Committee, has one of the world's most respected systems of oversight of scientific merit and ethical acceptability[5]. Cancer gene therapy trials involving UK clinical centres are not only funded by UK based public and private sector groups but have attracted funding from other European and US based pharmaceutical companies.


1  This figure excludes those services not normally provided on an in-patient basis, for example cancer screening, chemotherapy, radiotherapy and community palliative care services. Back
2  Many medical oncologists (and some clinical oncologists) undertake higher degrees (MD or PhD) which will equip them to undertake research. Back
3  This includes Medical Research Council and Department of Health support. It does not include Funding Council support for universities as it is not possible to identify the element supporting cancer. Back
4  This figure does not include Public Health Development fund activities. Back
5  Gene therapy trials also require approval of Research Ethics Committees and (pre-licensing) the Medicines Control Agency. Back

 
previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries index

© Parliamentary copyright 2000
Prepared 27 April 2000