Annex 1
Funding of Clinical Cancer Research Requires
a Fresh Look
The House of Commons Science and Technology
Committee has recently agreed to conduct an inquiry into cancer
research. The first of its terms of reference is concerned with
basic resources, ie:
"to inquire into the organisation, funding
and regulation of research into the causes, prevention and treatment
of cancer in the UK and the factors influencing its effectiveness
and translation into clinical practice, with particular reference
to: the adequacy or otherwise of the overall resource in cancer
research in the UK . . ."
We (HR & PC) recently undertook a survey
of 30 teaching hospitals and cancer centres, seeking to enumerate
this position. We felt this would be a useful piece of research
to aid in negotiating for improved resource allocation as the
next Culyer funding round is about to take place, three years
after the original initiative. The focus was oncology and the
changing income, activity costs and ratios between sponsored and
un-sponsored trial work in oncology specifically and more generally.
The response rate to the survey was poor. Of the 12 replies received,
some centres reported inability to provide the data sought due
to poor or total lack of management systems from which to source
data. Few had time to deal with the complexity of the issues raised.
Little research has been undertaken to study
resource allocation to support clinical research within the NHS.
Most of the work done has been carried out to identify resources
applied to non-sponsored research and remain generally unpublished.
This relates primarily to the Government's funding stream for
non-commercial research (MRC etc) and is identified under the
heading of "Culyer money". However, in reality, this
merely relabelled a government pot of money already in the system.
In the last research assessment exercise undertaken in 1996-97,
Trusts identified resources allocated to research in order to
secure the existing government funds. Some redistribution and
reallocation of this money between Trusts nation-wide followed
the "Culyer" investigations. However, while Trust clinical
staff co-operated in identifying all costs incurred in undertaking
clinical research over and above those involved in delivery of
core clinical services, expectations that each individual department
would in turn benefit by receiving "Culyer money" to
cover the costs were not met.
To make matters worse, while Trust funds to
meet clinical service delivery have come under increasing pressure
simply as a matter of service development and government imposed
resource limitations, Trusts are also required to support un-funded
research activity. A case in point is the apparent enforcement
of the MRC-NHS Concordat which requires that Trusts must provide
the resources to allow MRC-endorsed studies to be performed locally,
even though these trials are essentially un-funded and frequently
impose a considerable financial burden primarily in terms of expensive
new drugs. The tensions generated between starved researchers
and Trust managers struggling to deliver core services causes
internal argument and strife, while leaving government and regional
R&D directors surprisingly free from entanglement in the underlying
predicament of gross under-funding for clinical research within
the NHS and Universities of this country.
This unsatisfactory situation may in part be
addressed by charging the pharmaceutical industry for trial infrastructure
costs associated with commercial studies carried out in NHS establishments.
The industry is keen to access clinicians and patients in the
NHS and is prepared to pay for these valuable commodities. However,
industry probably avoids the true cost of access to NHS resources.
In most cases, a lump sum per enrolled patient is paid out to
a clinical research/Trust fund held by an individual researcher
or research department. The true infrastructure costs are rarely
fully calculated. In some centres this is not the case, but income
is then applied within the local environment, bypassing the business
planning/priority setting systems in the Trust. In some Trusts,
there are now legitimate initiatives to levy an additional charge
to companies for use of NHS facilities. Logically, this should
be offset by any income received from the company, perhaps as
free drug or sponsored research staff. It is certainly not acceptable
to paint the pharmaceutical industry as the "bad guys"
in the funding problems of clinical research. A recent review1
of drug funding in our own oncology centre identified that cytotoxic
drugs supplied by pharmaceutical companies for patients entered
into clinical trials of cancer therapy supplemented the annual
oncology expenditure by £143,800, equivalent to nine per
cent of the Trust-allocated departmental drug budget for the year
1998-99. Similar support probably occurs in most regional cancer
centres across the UK, but the extent of such subsidisation of
the NHS is not known.
What is known is that, in Oncology, clinical
research is made particularly difficult because of the large number
of complex, un-sponsored and time-consuming clinical trials undertaken.
From the few replies received relating to our original survey,
it appears that on average, two thirds of trials undertaken are
un-funded. In the case of commercially sponsored trials, free
drugs is certainly the main contributor to offsetting the costs
associated with the company accessing Trust resources. The balance
sheet across the whole trial portfolio relies heavily on such
accounting to present a case for the Trust continuing to participate
in un-sponsored research too.
The key neglected costs are those associated
with the service support costs, which involve departments of radiology,
pathology, and most particularly, pharmacy. In Oncology, where
around 80 per cent of trial work involves systemic therapy (data
collated from our survey), pharmacy support is key in terms of
chemotherapy preparation and overall trial support. The balance
sheet does not embrace such costs. Pharmacies have levied their
own charges in most cases, but usually only where a trial is sponsored.
In most other cases there are no resources to access and oncologists
are unwilling or unable to fund infrastructure costs in such circumstances.
Not infrequently, clinicians may not even be aware of the difficulties
experienced by other supporting departments and do not try to
obtain the limited resources which the MRC and similar organisations
may occasionally offer, inadequate though these usually are.
Chief Pharmacists in 24 UK teaching hospitals
have provided some data regarding how they meet the resource requirements
for supporting clinical trials locally (unpublished data received
from J. Dorey, Chief Pharmacist, Radcliffe Infirmary, Oxford,
collected from the Association of Teaching Hospital Pharmacists).
Table
SUMMARY OF TEACHING HOSPITALS SURVEY OF CHIEF
PHARMACISTS UNDERTAKING CLINICAL TRIALS
| Is a pharmacy charging policy in place?
| Yes
19 | No
4
| |
|
| How are income accounts managed? | Pharmacy managed—charitable
| Pharmacy managed—exchequer
| Pharmacy managed—training
| Trust held |
| | 11
| 9 | 1
| 2 |
| Are changes to this planned? | Yes
| No | Trust to take a %/levy additional cost*
| |
| | 7
| 16 | 2
(eg 16-33% levy)*
| |
| Any income for MRC/in-house studies? | Yes—MRC
| No—MRC | Minimal—MRC
| Minimal
in-house |
| | 2
| 16 | 3
| 10 |
| Are pharmacy trials support staff resourced?
| Yes—Trials income |
In establishment (not identified)
| |
|
| | 12
| 11 |
| |
| Is Culyer funding forthcoming? | Yes
| No | Nothing additional
| |
| | 0
| 16 | 7
| |
From this survey and our own, it is clear that all pharmacy
departments suffer from a complete lack of receipt of any Culyer
funding whatsoever. Pharmacists have been forced independently
to set up charging policies for their services, again, primarily
levied at commercial companies, but also charged to clinical researchers
undertaking "in-house" studies where research funding
has been allocated. These charging policies vary considerably.
For example, set-up fees varied from £250-400; dispensing
for non-aseptic work was usually around £10-20 per dispensed
occasion; aseptic dispensing charges depended on complexity and
ranged from £20-100 per dose; storage charges ranged from
£50-100; close-down fees from £50-100; out-of-hours
charges varied and were often paid directly to the individual.
The overall impression is that few hospitals (if any) are
funded at an economically viable level to support the obvious
costs of undertaking clinical cancer research, the burden of which
is primarily carried by the oncology department. However, just
as important are the more hidden costs to support services, namely,
pharmacy, radiology and pathology. The financial burdens on pharmacy
services imposed by oncology research is something few clinicians
anticipate or possible understand. It is essential that all bids
for funds for clinical trial work properly consider these support
costs. In oncology, developing a research profile and sustaining
it is really dependent on partnership working with, in particular,
the supporting pharmacy.
We would advocate a national strategy to develop uniformity
in all aspects of costing of clinical research within the NHS.
An open, multidisciplinary forum could identify the key costs
involved and develop a single charging system for pharmacies,
oncology departments and Trusts. Involvement of government bodies,
regional R&D Directors and key research organisations such
as the MRC would be key to revealing and addressing the problems
of all parties in the hope of overcoming the hurdles and barriers
we all face in our involvement in clinical research.
Innovative, fair and accurate costing systems must be put
in place which should be as useful to the NHS as to our commercial
partners. The pharmaceutical industry relies heavily on UK conducted
research to test and establish their products. The NHS requires
research to develop better treatment and improve patient outcomes
as a consequence. Clearly, there may be ways forward in developing
more effective partnerships with external sources.
Finally, there is clearly a need to engage the Government
in a debate about funding of both hospital-based research and
the introduction of new drugs which prove themselves through research
initiatives. The national R&D budget was actually cut this
year at a time when both service and research funds are stretched
further than ever before. It is difficult to convince clinicians
that this is a demonstration of the Government's commitment to
clinical research in this country. The issue of affordability
of new, expensive oncology treatments will be addressed by NICE,
and their recommendations on the taxoids later this year is awaited.
However, it is clear that NICE will not have time to address the
growing number of new oncology products being licensed but yet
not introduced into clinical practice uniformly because of cost
pressures. How will we address these new developments?
REFERENCE
1. P de Takats et al. Clinical trials of cancer
treatment conceal the true financial cost of providing highest
quality patient care. Cancer Strategy 1999; 1:141-44.
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