APPENDIX 5
Memorandum submitted by Dr Ann Johnson,
Breast Study Centre, Mount Vernon Hospital, Northwood
INTRODUCTION
1. I run the Breast Study Centre which is devoted
to clinical research in breast cancer. I hold an honorary consultant
contract. I have had experience in surgery, radiotherapy and oncology
and in clinical research. Between 1979 and 1987 the Breast Study
Centre operated as a dedicated specialist breast cancer clinic
under the leadership of the late Dr R H Thomlinson, who was a
member of the Medical Research Council's (MRC) External Scientific
Staff. The MRC withdrew their support for the Clinic in 1984.
The patients, threatened with the loss of a service that they
valued, set up an Appeal and raised sufficient monies to keep
the Clinic going until Dr Thomlinson's retirement in 1987. I was
unable to raise any long-term support from mainstream cancer charities
and was obliged to close the Clinic in 1988. I have since eked
out the residual funds to enable me to complete the analysis of
the data that we had amassed and to write it up for publication.
This task is nearly complete.
2. The Breast Study Centre must have been
amongst the first dedicated breast clinics in a purpose-designed
building in this country. We concentrated upon the individual
management of breast cancers through careful measurement of the
response of the primary tumour to treatment with drugs and radiation.
The results confirm that "breast cancer" represents
a wide range of different behaviours—one treatment is not
appropriate for all.
3. The accumulated expertise of the Centre
is relevant to considerations of "the roles and policies
of the MRC and cancer charities in cancer research and clinical
trials", "the suitability of NHS oncology centres for
the prosecution of clinical trials", "the value and
status of research amongst NHS clinical oncologists" and
"the application of NHS R&D funds to clinical oncology
research".
4. I restrict my comments to clinical research.
PHILOSOPHY OF
CLINICAL RESEARCH
5. There is a prevailing assumption that
anyone can/should do research. Young trainees must produce research
papers to further their careers. The Royal College of Surgeons
has set up funding for short-term projects by trainee surgeons.
6. "Clinical research" has become
virtually synonymous with "clinical trial". This has
resulted from the wholesale adoption of the order of merit of
research results that puts meta-analysis of randomised, controlled
clinical trials in the &+ position, closely followed by the
randomised trial. Good observational data are well down the list
(see Appendix 1[1]).
7. Breast cancer is apparently conceived
as a straightforward entity for which an ideal management must
exist. In the light of paragraph 2 this leads to large clinical
trials that examine different treatments in groups of patients
matched for everything except the variability of their cancers.
(see Appendix 2[2])
APPOINTMENTS AND
FUNDING
8. Full time research posts are now rare.
The MRC no longer appoints to the External Scientific Staff. But
security tenure is essential for the development of good investigations,
particularly in breast cancer, where the timescale is very long.
Trainees in short-term posts do not stay to see the results of
their treatments. Oncology research posts are usually limited
to a few sessions as part of a general commitment.
9. The Calman-Hine training model works
against breast cancer research by placing treatment in the district
hospitals rather than the cancer centre. Close collaboration between
all members of the team of specialists required for effective
management of breast cancer demands a specialist clinic—as
recommended by the British Breast Group (Appendix 3[3]).
In such a collaboration research will form an integral part.
10. Academic posts are relatively poorly
paid, on university scales, in comparison with clinical salaries.
11. Funding has become short-term. Much
time is wasted in preparing grant applications for three to five
year periods.
12. In the current climate of shortages,
only a+ rated projects are funded, thus perpetuating clinical
trials at the expense of other methods of investigations (See
para 6).
DELETERIOUS EFFECTS
OF PHILOSOPHY
AND FUNDING
METHODS
13. Long-term projects are discouraged.
14. Data are lost through lack of continuity
and loss of control of the infrastructure. For example, hospital
notes, x-rays and scans have a prescribed lifetime, after which
they are discarded, and hospitals lose their identity when Trusts
merge. The retention of important notes and specimens depends
upon organisational structure that can only be maintained by long-term
appointees.
15. Clinical research involves a population
of patients. Where there is no continuity these patients are disadvantaged
through loss of the doctor who knew their case and the breaking
up of the support group formed by their fellow patients. I have
encountered many instances of this kind of failure since I was
compelled to close my clinic.
Mr Michael Foster
16. Since there is a very wide range of
behaviour of breast cancers, there is a need for good observational
research eg measurement of response in relation to intrinsic features
of a particular cancer. This cannot be achieved in a randomised
trial and therefore progress is very slow.
SUGGESTIONS FOR
IMPROVEMENT OF
CLINICAL RESEARCH
IN BREAST
CANCER
17. Set up specialist breast clinics that
include long-term appointments for dedicated research workers.
18. Redress the imbalance of long-term/short-term
projects.
19. Accept that "breast cancer"
is a group of widely varying tumours that happen to originate
in one organ and that the individual characteristics of differing
types must be investigated separately.
20. Accept, therefore, that the randomised
clinical trial is a poor tool for clinical research in breast
cancer and fund more observation of individual patients. A model
was proposed by the haematologists in the North-East Region (population-adjusted
clinical epidemiology, PACE, but it was not funded—see Appendix
4).
21. Encourage and fund consumer involvement
in the choice of research topics and planning of investigations.
The Breast Study Centre experience was that this kind of collaboration
is highly productive.
APPENDICES[4]
1. Johnson, AE, Riposte to Guest Commentaries
on "Problems associated with randomised controlled clinical
trials in breast cancer" Journal of Evaluation in Clinical
Practice, 1996, 4, 231-236.
2. Johnson, Ann E. Editorial Clinical Update,
1996. Volume 22 Number 10.
3. Provision of breast services in the UK:
the advantages of specialist breast units. Report of a working
party of the British Breast Group. Published by the Breast in
1994.
4. Charlton, BG, Taylor, PRA and Proctor,
SJ The PACE (population-adjusted clinical epidemiology) strategy:
a new approach to multi-centred clinical research Quarterly Journal
of Medicine, 1997, 90, 147-151.
1 March 2000
1 Not printed. Back
2
Not printed. Back
3
Not printed. Back
4
Not printed. Back
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