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
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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)