Permitting patients to pay for participation in clinical trials: the advent of the P4 trial

Medicine, Health Care and Philosophy, Oct 2016

In this article we explore the ethical issues raised by permitting patients to pay for participation (P4) in clinical trials, and discuss whether there are any categorical objections to this practice. We address key considerations concerning payment for participation in trials, including patient autonomy, risk/benefit and justice, taking account of two previous critiques of the ethics of P4. We conclude that such trials could be ethical under certain strict conditions, but only if other potential sources of funding have first been explored or are unavailable.

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Permitting patients to pay for participation in clinical trials: the advent of the P4 trial

Permitting patients to pay for participation in clinical trials: the advent of the P4 trial David Shaw 0 1 2 Guido de Wert 0 1 2 Wybo Dondorp 0 1 2 David Townend 0 1 2 Gerard Bos 0 1 2 Michel van Gelder 0 1 2 0 Institute for Biomedical Ethics, University of Basel , Basel , Switzerland 1 Maastricht University Medical Centre , Maastricht , The Netherlands 2 Department of Health, Ethics and Society, CAPHRI Research School, Maastricht University , Maastricht , The Netherlands In this article we explore the ethical issues raised by permitting patients to pay for participation (P4) in clinical trials, and discuss whether there are any categorical objections to this practice. We address key considerations concerning payment for participation in trials, including patient autonomy, risk/benefit and justice, taking account of two previous critiques of the ethics of P4. We conclude that such trials could be ethical under certain strict conditions, but only if other potential sources of funding have first been explored or are unavailable. Clinical trials research; Exploitation; Crowdfunding; Research ethics; Patient participation - Imagine that you are suffering from terminal cancer and you’ve heard about a clinical trial that aims to test a promising new drug in humans for the first time. You’re keen to enroll as your current treatment is no longer effective. On reading the information sheet and consent form, you are surprised to see that participation in the trial will cost 20,000 Euros because of the high cost of the drug Autonomy and justice: categorical objections When faced with the proposal to ask patients to pay for participation in clinical trials, some people might reflexively react that this is simply unethical, even without detailed exploration of the relevant issues. There are two main reasons that might underpin this stance. First, patients in general are a potentially vulnerable group, and involving them in research is already ethically challenging even under normal circumstances. Terminally ill patients are a particularly vulnerable group, and asking such patients to contribute considerable sums in exchange for involvement in research raises serious concerns about autonomy and exploitation. Under what conditions should an individual be judged competent to invest large sums in an uncertain research enterprise? Furthermore, while some patients are well-off, others are very poor, and might incur large debts by borrowing substantial sums in order to participate in a trial (assuming that they had sufficient collateral to secure a loan). Emanuel et al. (2015) argue that what they call ‘‘pay to play’’ trials should be prohibited, in part because of such considerations: Pay-to-play research is less likely to be a collaborative partnership than a psychological exploitation of individuals desperate to do anything to save their own or a loved one’s life. Although willingness to pay might indicate understanding and voluntariness by participants, it might also reveal unrealistic expectations and undue pressure. The chances for success of early phase experimental drugs are much smaller than either researchers or laypeople think. The vast majority of experimental agents, *90 %, that enter human trials even under current circumstances fail primarily for reasons of safety and efficacy. These are serious concerns, but they are not of a categorical nature: while it is true that asking for payment may contribute to the therapeutic misconception, terminally ill patients are usually judged competent to give consent to enter a potentially risky clinical trial, and it is not obvious that adding a fee to the equation changes things fundamentally. Furthermore, even if it were shown that P4 trial participants were more prone to the therapeutic misconception (where participation in research is mistaken for involvement in clinical therapy), steps other than prohibition could be taken to address this. For example, patients could be informed that 90 % of new drug trials fail, and reminded very clearly that seeking clinical benefit from such a trial is likely to be a futile endeavour (see ‘‘Risk, benefit and trial design’’ section). Taking these extra steps would address the worry of Emanuel et al. that participants are ‘‘likely to overestimate the chances of a successful outcome.’’ Ironically, Emanuel et al. themselves fall victim to the therapeutic misconception when considering the social value of P4 trials; they state that ‘‘buying into a clinical trial ultimately constitutes the purchasing of a good or service that happens to contribute social value as a side effect.’’ But this gets things the wrong way round: those who ‘‘pay to play’’ are paying for participation in a trial that aims to provide social value through generalisable knowledge. The goods and services they pay for are involvement in research, with all its uncertainties; any benefit to the patient/participant is actually a side effect. Emanuel et al. also rais (...truncated)


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David Shaw, Guido de Wert, Wybo Dondorp, David Townend, Gerard Bos, Michel van Gelder. Permitting patients to pay for participation in clinical trials: the advent of the P4 trial, Medicine, Health Care and Philosophy, 2017, pp. 219-227, Volume 20, Issue 2, DOI: 10.1007/s11019-016-9741-2