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 Collections under
which this article appears: Randomized
Controlled Trials: descriptions Informed
Consent Competing
interests / conflicts of interest |
Jammi N Rao
a West Midlands Multicentre Research Ethics Committee, 27 Highfield Road, Birmingham B15 3DP, b Coventry Research Ethics Committee, University Hospitals Coventry NHS Trust, Coventry CV2 2DX
Correspondence to: Dr Rao jammi@bharat.demon.co.uk
Financial advisers who sell you insurance or mortgages are required by the rules to tell you how much commission they will earn as a result of your custom. But doctors who ask patients under their care to take part in a clinical trial are under no obligation to reveal how much they might earn as a result of their patients agreeing to take part in the trial. Can this be right?
Of course, the situation is not quite as simple as this. Selling insurance, one could argue, is not the same as inviting a patient to take part in a clinical trial. If the doctor was not reimbursed generously for his time then important clinical research would just not get done.1 The doctor can be trusted to put the best interests of the patient above personal gain, and therefore telling potential trial subjects how much the doctor will be paid is unnecessary. Do these arguments stand up to closer scrutiny? Or has the practice and scale of payments reached a point where it has become harmful to the conduct of good research?
Randomised clinical trials, often sponsored by pharmaceutical companies with
a valid commercial as much as a genuinely scientific interest, are
the only reliable way to generate good quality evidence of efficacy.2
Clinicians ideally should be in equipoise about the treatments being
tested,3 and patients should give voluntary
consent based on full disclosure of relevant information.4
The practice of paying doctors to recruit patients under their
care, and not disclosing this pecuniary interest, corrupts both these
ideals.
| Summary points
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Paying recruiters is wrong in principle |
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Cash payments can potentially influence doctors' motives for joining a clinical trial. Some trials are designed by clinicians, often working with patients,5 to answer important clinical questions. Other trials, especially in general practice, are different. They are sponsored and funded by pharmaceutical companies and are designed to achieve objectives that are at least in part commercially determined. Doctors who join have little or no control over the research question, design, methods, safety monitoring, analysis, reporting, or even the decision whether or not to publish the results.6 Such trials depend on paying doctors to recruit patients. The size of the payment and not the buzz of research is what motivates doctors to join such trials.
Over the years we have seen the payments on offer soar to thousands of pounds
per completed patient. Well organised British general practices can
earn an extra £15 000 annually for three hours' work a week.7
As a result, trials designed by non-commercial sponsors aiming to
answer clinically important questions but without the funding
available to pay recruiters fail to attract doctors.8
So called postmarketing research (phase IV studies) is the biggest
culprit. As uncontrolled observational cohort studies, these studies
make no attempt to address important areas of clinical uncertainty.
Their stated purpose is to familiarise doctors with new and recently
licensed drugs.9 This is marketing thinly
disguised as research and is greatly helped by
and
probably not possible withouta
system of undisclosed payments.
A system that allows commercially driven and clinically dubious research to
crowd out good and much needed clinical trials, and that denies
patients the opportunity to put their altruism to the best possible
use, is unethical and unacceptable.
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Not disclosing payments compounds the harm |
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Because of the potential conflict of interest inherent in paying doctors to recruit patients in their care, guidelines on research ethics deal with this question. The Royal College of Physicians' guidance,10 for example, insists that such payments are divulged to a research ethics committee. It states that per capita payments, especially for postmarketing studies, are unethical; but reimbursement for time spent is acceptable and should be declared to an ethics committee.
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Payments, often overtly on a per capita basis, have reached levels that are of serious concern to research ethics committees. Commercial sponsors regularly flout the implicit ban on per capita payments by claiming to pay for the work involved in conducting the trial (rather than for recruiting patients), and then overestimating the amount of time required for each patient. Such payments are in addition to the doctor's regular income and can result either in overwork or in displacing other more pressing clinical activity. Anecdotally we have heard that some hospital departments depend on regular income from patient recruitment and that some general practitioners have set up systems to trawl their databases to find patients who fit the requirements for a particular sponsor's study to improve their recruitment rates.
The lack of disclosure to patients can potentially be damaging. We acknowledge the potential for unethical practice by requiring that the amount and basis of payments are disclosed to a research ethics committee. However, this does not go far enough. Not to require a similar disclosure to patients is as cynical as it is demanding of blind and unquestioning trust. Patients who take part in trials do so at least partly from altruism.11 Failure to reveal the conflict of interest that is inherent in payments that doctors receive from the trial sponsors is not a good basis for involving patients in the research endeavour. One American study found that just over half of patients questioned found payments to clinicians unacceptable. An even greater proportion (80%) believed that the patient had a right to know that their doctor would be paid for enrolling them (see figure).9
A change to the regulatory framework making full disclosure mandatory would
not meet with opposition. Until 1997 it was the practice of one of
our ethics committees (LJSC) to insist on full disclosure in the
patient information sheet of the exact amount of payments to the
investigator. In most cases neither the sponsor nor the investigator
objected to this policy. The opportunity presented by the new system
of multicentre research ethics committees to achieve a consistent
approach on this question has not been taken up. The attitude still
prevails that patients can always ask about payments if this is
important to them. But it is disingenuous to expect patients to know
that something they have not been told anything about is important
enough for them to ask about.
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Conclusion |
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Consent obtained on the basis of withholding information on an issue that
patients consider important is not fully informed consent. If we are
ever to reach the ideal of involving patients in the design and
conduct of clinical trials5 then we could
do worse than treat patients as equal partners by making full
and frank disclosure of payments that trial sponsors make to doctors
for recruiting their patients.12
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Footnotes |
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Funding: None
Competing interests: None
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References |
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| 1. | Foy R, Parry P, McAvoy B. Clinical trials in primary care. BMJ 1998; 317: 1168-1169[Full Text]. |
| 2. | Chalmers I. Unbiased, relevant and reliable assessments in health care. BMJ 1998; 317: 1167-1168[Full Text]. |
| 3. | Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987; 317: 141-145[Abstract]. |
| 4. | Gillon R. Medical ethics: four principles plus attention to scope. BMJ 1994; 309: 184-188[Full Text]. |
| 5. | How consumers can and should improve clinical trials. Lancet 2001; 357: 1721[Medline]. |
| 6. | The tightening grip of big pharma. Lancet 2001; 357: 1141[Medline]. |
| 7. | Income generation. Medeconomics 1996; Aug: 44. |
| 8. | Wilson S, Delaney B, Roalfe A, Hobbs R. Clinical trials in primary care. Costs of research should not be borne by service practitioners. BMJ 1999; 318: 1484[Full Text]. |
| 9. | La Puma J, Stocking CB, Rhoades WD. Financial ties as part of informed consent to postmarketing research. Attitudes of American doctors and patients. BMJ 1995; 310: 1660-1661[Full Text]. |
| 10. | Royal College of Physicians. Research involving patients. London: Royal College of Physicians, 1990. |
| 11. | Rao JN. Patients' altruism should be appreciated. BMJ 2000; 321: 1530. |
| 12. | Neuberger J. An ethical debate. Financial ties as part of informed consent to postmarketing research: From the patient's perspective. BMJ 1995; 310: 1661-1662[Full Text]. |
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Collections under
which this article appears:Randomized
Controlled Trials: descriptions Informed
Consent Competing
interests / conflicts of interest |
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