Evidence that ‘finder’s fees’ and other recruitment incentives are increasingly being used to secure participants for clinical trials in North America has raised concerns about the effect on physicians’ judgment, patient safety and public confidence in clinical research.
Writing in the August issue of PLoS Medicine, Trudo Lemmens and Paul Miller of the University of Toronto suggest the long-term solution may lie in drastic changes to the whole structure of clinical development, such as setting up independent national institutes to test medicines.
That would tackle the problem at root by stemming the growing competition for trial subjects, which has led to finder’s fees of anything from US$2,000 to US$5,000 per patient, Lemmens and Miller say. More immediately, regulatory and professional agencies should look at tightening up conflict-of-interest rules, not only within academic institutions but also among the institutional review boards that typically review and manage conflicts of interest in clinical studies.
With the number, size and cost of clinical trials piling up, patient recruitment has become a critical challenge for the pharmaceutical industry, the authors comment. Hence the growing recourse to recruitment incentives, be they direct payments to healthcare professionals for recruiting research participants or less blunt forms of persuasion such as authorship priority, paid consulting work or further research sponsorship.
Lemmens and Miller see these incentives as compromising the integrity of clinical research on three levels. Physicians may be tempted to act against the best interests of their patients or to manipulate consent procedures. Patients may find themselves at risk if researchers disregard inclusion or exclusion criteria for trials. And the public interest in sound clinical science is further undermined, with recruitment incentives distorting research priorities in favour of commercially driven agendas.
There are already some controls on recruitment incentives, the authors point out. The American Medical Association’s Council on Ethical and Judicial Affairs has stated in one opinion that “offering or accepting payment for referring patients to research studies (finder’s fees”) is unethical”. A number of academic institutions expressly prohibit finder’s fees. However, since most clinical trials are now conducted outside academic institutions, this sort of guidance has little impact in practice, Lemmens and Miller add.
Physicians could also face legal and regulatory sanctions if they accept recruitment incentives. Exposure to tort liability is one consequence of a physician purposefully misinforming, or failing adequately to inform, a patient about financial interests, the authors note. The penalties may even go as far as criminal charges. For example, statutory frameworks on professional misconduct in most US states and some Canadian provinces generally rule out the offer or acceptance of rewards for referring patients to healthcare providers or facilities.
Nonetheless, the problems created by finder’s fees “cannot be resolved by focusing exclusively on sanctioning the individuals who may accept them”, Lemmens and Miller warn. Rather, they should be confronted “as part of a broader institutional and regulatory reform effort designed to address weaknesses in research governance”. In the meantime, the authors claim, patients taking part in clinical trials have “become de facto market products, while ‘market controls’ are neither clear nor sufficiently stringent”.
Nor is the problem confined to North America. A more global economy means more ‘jurisdiction shopping’, with clinical trials shifting increasingly to “middle- or low-income countries, where recruitment and other research-related costs are cheaper, where regulations either do not exist or may not be adequately enforced, and where research participants are even more vulnerable”.