Clinical trials in primary care
BMJ 1998; 317 doi: https://doi.org/10.1136/bmj.317.7167.1168 (Published 31 October 1998) Cite this as: BMJ 1998;317:1168
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Dear Sir
Foy, Parry and McAvoy's (1) support for financial incentives to
encourage GPs to recruit patients into clinical trials is flawed. There
are major ethical problems with the present system of payments to
clincians for recruiting patients into pharmaceutical company sponsored
trials.(2). These are:
1. The paymaster sets the research question, designs the trial and
analyses the data. The sponsor (usually a drug company) owns the data and
determines how, when and if the results are published. There may not be
the clinical equipoise that ethically justifies and mandates a trial. In
this situation the recruiting doctor is little more than a bounty hunter.
2. Payments have reached disproportionate levels. There are
guidelines of course (3), but these are so vaguely worded as to be
meaningless. The ban on per capita payment is flouted by the simple
expedient of paying per hour of work. The estimated number of hours of
work is inflated and the standard BMA rate of £100 per hour is then
applied to make clinical trials a relatively lucrative trade. Either the
care of other patients suffers or the estimated work involved is inflated.
3. None of this would matter if ethical principles were not
compromised. They are. And regularly so. Despite the call for safeguards
and ethical review notwithstanding, it is impossible to be sure that truly
informed consent is obtained when the doctor retains a financial interest
in securing a positive consent. To this end information leaflets are
written with a slant to persuade the patient to consent. It never mentions
how much the doctor will receive. In some studies the doctor has a vested
interest in keeping the patient in the trial and this may be seen to
compromise patient autonomy.
4. If payments become the norm, then the amount paid and not the
worth of the research project will determine which trials get done.
Pharmaceutical firms often use a clinical trial to introduce a relatively
new, but already licensed drug to prescribers. Financial incentives to
clinicians are essential for this strategy to succeed. The company
sponsored marketing exercise dressed up as a clinical research trial will
crowd out the necessary clinical trial. Scarce research time will thus be
allocated on the basis of commercial rather than clinical priority. At the
macro level this must be unethical.
5. Lastly, patients are kept in the dark. By some strange logic, the
guidelines would have us believe that it is unethical to remunerate
patients for entering into a trial, but it is okay not only to pay
clinicians handsomely but also not to require them to disclose this fact
to patients when seeking consent.
The most demanding clinical trials must be those on cancer and these
get by and achieve very good recruitment rates without any payments made
to doctors. In contrast many studies in primary care that are sponsored by
pharmaceutical companies address a question of doubtful value and involve
large payments to doctors.
In contrast to the conclusion of Foy's editorial, my work on ethics
committees leads me to suggest that individual clinicians should not
benefit financially from recruiting patients under their care to a
clinical trial. The guidelines need to be updated and made clearer and
less capable of circumvention. Pharmaceutical companies should employ
doctors (or preferably nurses) to carry out the work of making and
recording clinical observations, but on patients they do not themselves
recruit. In a given area, these may well be the same GPs but they would be
studying patients recruited by other doctors in the area.
I firmly believe it is wrong for clinicians to recruit their own
patients into clinical trials for financial gain.
References.
1. Foy R, Parry J, McAvoy B. Clinical trials in primary care. BMJ
1998; 317:1168-9
2. Rao JN. Payment doctors for clinical trials is unethical. Paper
presented at the Summer Conference of the Faculty of Public Health
Medicine, June 1998, Torquay, England.
3. Guidelines on the practice of ethics committees in medical research
involving human subjects. 3rd Edition. The Royal College of Physicians of
London, August 1996
Jammi N Rao, FRCP MFPHM
Chairman, Sandwell Local Research Ethics Committee
(600 words)
Competing interests: No competing interests
The Ethics of Paying GPs
Foy et al[1] debate the role of "financial incentives" to improve
the recruitment of patients to primary care based trials. However, the
critical issue should, more properly, be described as whether the real
costs of research should be borne by service practitioners. We suggest
that they should not. This is especially true of UK general practice since
the NHS has an exclusively service agreement with the independent
contractors in general practice. Indeed, the new Budget 1 (Culyer) funding
mechanism has set aside 'ad-hoc' funding specifically to meet the 'excess
service costs' of supporting research in primary care.
Ethical trials require participating clinicians and patients to be in
equipoise and for informed consent to be obtained. Assessing eligibility,
explaining a trial, addressing patients' questions, obtaining consent,
randomising and undertaking baseline data collection is a time consuming
business. Grant proposals should include the true cost of research
studies. Funding bodies cover research staff salaries and overheads,
general practitioners should not be expected to give their time freely.
A primary care based randomised controlled trial of the cost-
effectiveness of open-access endoscopy and testing for Helicobacter Pylori
in the management of dyspepsia has recruited 920 dyspeptic patients from
44 general practices in the West Midlands region. Patients were recruited
opportunistically within the consultation. We initially allowed ten
minutes for these activities and reimbursed excess costs at a rate of £10
per patient recruited. After the first year, a more realistic assessment
of the time commitment involved in patient recruitment was made. The
practitioner time, exclusive of administrative costs, was estimated as 30
minutes per patient recruited. This additional workload led to some
practices suspending recruitment at 'busy' times (Monday mornings,
holidays, flu season etc.). Our revised time estimates resulted in
increasing the payment to £50/patient recruited (BMA suggested rate of
£108 per hour).
We have recently examined practice recruitment rates during the study
(Figure). The observed improvement in recruitment rates could be ascribed
to the introduction of a more acceptable level of payment, although this
is unlikely to be the sole explanation. We attribute the improved
recruitment to the combined effect of several measures introduced around
this period; namely, simplification of the study design, re-emphasising
the importance of the trial, regular newsletters, adequate financial re-
imbursement and an adaptable approach to the differing work patterns in
each practice.
Research into the effectiveness of interventions in primary care
needs to be undertaken in the general practice setting.[2 3] The
undertaking of research has always had financial implications. Direct
payments to GPs are no different to the more traditional forms of
institutional support.
Sources of funding: NHSE Primary Secondary Interface Programme &
NHSE (West Midlands) R&D
Conflict of Interest: None
References
1 Foy R, Parry J, McAvoy B. Clinical trials in primary care;
targeted payments for trials may help improve recruitment and quality. BMJ
1998;317:1168-1169
2 Mant, D. R&D in Primary Care: National Working Group Report. 1997.
Bristol, NHS Executive.
3 MRC. MRC Topic Review; Primary Health Care Research Review. 1997.
London, MRC.
The author would like to acknowledge Dr B Delaney, Ms Andrea Roalfe and Professor R Hobbs as co-authors.
Competing interests: No competing interests