MEMORANDUM SUBMITTED BY THE DEPARTMENT
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
- Role of National Institute of Clinical Excellence
- DH/NHS R&D Support for Cancer Research
- Role of NHS in supporting clinical trials
- Cancer Gene Therapy
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.
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 preventablearound
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
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.
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
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 CancerMajor 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.
trial of chemoprevention (Tamoxifen) and studies to improve the
use of mammography in screening (Breast Screening Frequency Trial
and Breast Screening Age Trial).
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
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 trialsMechanisms
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
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
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
12. The Government is making a substantial
contribution, currently over £110 million
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
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
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 streamsNHS
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.
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
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 industrywhich, 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
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
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
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
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.
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.
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 resourceseither 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
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
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.
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;
other UK Health Departments also
invest in health research.
NHS RESEARCH AND
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 budgetsNHS Support for Science and NHS Priorities
R&D SUPPORT FOR
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
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
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
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.
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.
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
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.
BY NHS REGIONAL
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
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.
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;
feasibility of research;
likely return on the investment in
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
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.
FUNDED R&D ON
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
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.
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
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
24. The expenditure on Cancer R&D by
DH/NHS R&D for 1998-99 is as follows:
|Policy Research Programme||2.1
|R&D Support for NHS Providers||63.0
|NHS R&D Programmes||4.0
|Other DH R&D
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
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
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 modewhere 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
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
4. INCREASING PARTICIPATION
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
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
The NHS R&D programme has also commissioned research
into the ethics of clinical trialsincluding 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.
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.
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
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
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
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