APPENDIX 49
Memorandum submitted by Professor Alan
K Burnett, on behalf of the MRC Adult Leukaemia Working Party,
University of Wales
I INTRODUCTION
The Haematology Community in the UK has successfully
conducted clinical trials in Haematological Cancers in more than
200 hospitals. This network has been established over 25 years
but has increased in participation and recruitment in the last
10 years. The major thrust has been under the auspices of the
Medical Research Council. This highly successful and internationally
respected organisation is now under threat. This memorandum outlines
the key issues which the Committee may wish to consider.
II BACKGROUND
For Acute Leukaemia, this organisation is highly
effective, producing the largest—and therefore the most
reliable—trials in the world. The five year survival of
patients under 60 years has improved from 12 per cent in the 1970s
to the present 50 per cent, which is superior to any other results
so far reported.
Many clinical questions have been addressed.
It is noteworthy that small centres in District Hospitals achieve
the same survival as teaching centres. This is of major social
advantage to patients who can access the best available treatment
in the world. This is an object lesson in protocol driven cancer
treatment and provides an internationally unique data set to monitor
improvement in survival.
It is not the purpose of this memorandum to
list the catalogue of clinical issues resolved by this network.
III THE PROBLEM
For many years this organisation was in the
unique and fortunate position of receiving ring-fenced funding
from the MRC. Several trials had industrial support as a minor
component. In recent years several associated laboratory studies
have been independently funded by MRC or Leukaemia Research Fund
project grants.
This highly successful organisation is now under
threat because of the recent change of MRC policy, whereby trials
now have to be individually funded and the previous ring-fencing
removed.
It is perfectly understandable to introduce
a new rigour to the trial scrutiny but we have already come to
find that the MRC has insufficient funds to fund all applications
that receive high scientific rating. The consequence of this is
that there will be a lack of continuity for haematological cancer
trials in the UK. This will result in dispersal of this valuable
and successful organisation. This will result in deterioration
in patient care. The MRC trial experience is a major evidence
base for evidence based medicine, which is essential to the NHS
priorities of NICE and the Calman-Hine Initiatives.
IV A SOLUTION
Given the new circumstances it is appropriate
to review how such trial activity should be enabled in the future.
Since the activity is of interest to many parties, The Adult Working
Party would like to see a consortium of support being developed.
It is understandable that the MRC should not be the sole financial
contributor. Industry and the network have mutual interest in
developing new initiatives. In this, the Working Party has a major
opportunity internationally to compete for new treatments. However,
the organisation has to be underpinned in order to be in a position
to bid for such initiatives. The trials are of very major clinical
and economic benefit to the NHS. Failure to have proper trials
will not establish a robust evidence base for the introduction
of new trials. We propose that NHS R&D should be financially
enabled and under an obligation to be a significant contributor
to supporting this network. Local investigators need Trusts to
support trial participation.
Central ethical review (MREC) has made life
easier at grass-root level. Data support remains the major obstacle
at local level. A simple solution could be to require Trusts to
enable trial entry as a Cancer Standard on a par with the political
importance of waiting time and other Cancer Standards.
V HOW MUCH
MONEY IS
NEEDED?
Maintaining the network, central trial mangement,
data management at a professional level will in our experience
cost £400 to £500 per patient. This is a small sum equivalent
to two-three days of some antibiotics and a fraction of the cost
of treatment.
VI SUMMARY
We hope that The Committee will consider facilitating
a partnership/consortium between relevant partners (eg MRC, NHS
R&D) to underpin the major groups consulting national studies,
ie the Adult and Paediatric Working Parties and Lymphoma Groups
such as the BNLI. The key issue is maintaining continuity. These
networks should not be exempt from robust peer review of its effectiveness.
28 April 2000
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