Annex 1
MRC LEUKAEMIA TRIALS: ACHIEVEMENTS TO DATE
1.1 The treatment of acute leukaemia in the UK,
for both adults and children, has benefited greatly from the structured
organisation and networking within national trials over the last
30 years. These trials have been supported by the Medical Research
Council and have led to substantial improvement in survival rates
(figures 1, 2, 3). They are now recognised as amongst the most
influential trials worldwide and their success has led to participation
and collaboration by other respected national groups. In the UK,
recruitment has steadily increased with over 90 per cent of children
now treated on MRC Leukaemia Trials. Such recruitment, for both
adult and childhood leukaemia, has allowed these trials to be
amongst the largest in the world facilitating a series of important
questions about leukaemia treatment to be addressed in a logical
and sequential manner over the years.
1.2 National trials with their proven ability
to recruit large number of patients have not only shown themselves
capable of evaluating new treatment regimes, but have also provided
a very large clinical database extending back over 30 years. This
database is an unequalled resource for evidence based treatment
which is now crucial with the establishment of the National Institute
for Clinical Excellence. Past trials have identified new treatments
which have led to an improvement in survival but as importantly
have shown some expensive new drugs or treatment modalities to
be of no benefit. It is of importance to note that continued improvement
in outcome and evaluation of treatment modalities have taken place
in over 200 district hospitals in the UK as well as in teaching
centres showing the benefit of maintaining structured and successful
networking.
1.3 The Leukaemia Research Fund has been
an important partner in the success of leukaemia treatment by
funding Clinical Training Fellowships and grants to support associated
scientific projects and more recently by sponsoring smaller development
trials to test new treatment options before more extensive trial
evaluation. In addition, the LRF supported Acute Leukaemia Cytogenetic
Database at the Royal Free School of Medicine, London provides
an important resource for peer review of cytogenetic data and
correlation of findings with outcome.
CURRENT CONCERNS
21 The present structure, which allows effective
networking and has led to the success of leukaemia treatment,
is now under significant threat because of insufficient finance
within the MRC to allow continued support of highly rated, peer-reviewed
trial proposals as has happened in the past.
2.2 There are major implications of not
sustaining the present network. Firstly, in the absence of supported
clinical trials recruitment would fall off. Secondly, there is
the risk of expensive new approaches being introduced in an ad
hoc manner without proper evaluation by trial. Thirdly, the improvement
in outcome may not be sustained. It must be obvious that the present
network is one of the principal reasons for the improvement in
outcome seen over the last 20 years, is essential to future progress,
is an asset to the National Health Service and represents a model
for clinical research of cancer.
2.3 It is essential, as a matter of urgency,
to find a way of maintaining the present successful system which
may involve a partnership of resourcing between the NHS, the MRC,
and Medical Charities; principally the LRF for leukaemia treatment.
Professor Alan Burnett
Chair MRC Adult Leukaemia
Working PartyDr Brenda Gibson
Chair MRC Paediatric Leukaemia
Working Party
LRF CLINICAL TRIALS ADVISORY PANEL
TERMS OF
REFERENCE
(i) to promote the highest quality of clinical
research within the context of clinical trials
(ii) to promote phase II/small phase III
trials of new chemotherapy and biological entities as a precursor
to definitive phase III trials
(iii) to peer review applications for the
funding of trials from established expert trial groups
(iv) to identify new opportunities for trial
support
(v) to recommend funding options to the
LRF Executive Committee
(vi) to liaise with the NHS, the MRC and
other funding agencies and with international trial groups
(vii) to ensure trials, data collection
and analysis are conducted on the basis of GCP guidelines
(viii) to monitor the progress of trials
by annual reports and, if appropriate, audit
(ix) to liaise with the LRF Medical &
Scientific Advisory Panel for the inclusion of research projects
as integral components of trials whenever possible
(x) to ensure the publication and dissemination
of trial outcomes within an agreed time frame
(xi) to promote regular review meetings
and, when appropriate, workshops etc. to disseminate information
to trialists
(xii) to support the LRF website for trial
organisers and patient advocacy groups.
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