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That's true. Good Clinical Practice guidelines say that Institutional Review Boards must evaluate compensation is not too high otherwise it constitutes "undue influence". ...but I think that's a terrible idea. I understand that, to come up with a far-fetched example, high compensation could result in some weird edge cases where, for example, a Phase I trial with healthy volunteers and a non-preventive drug candidate (e.g. an antibiotic rather than a COVID vaccine), but you're confident that drug is going to kill 99% of the volunteers so you offer $10 million to each volunteer. A totally informed volunteer might view this as something akin to a life insurance policy that pays out to the family even upon suicide. I don't personally see an ethical problem with that so long as volunteers are really well-informed, but I could see how others and the law would be uncomfortable with the ethics of such a situation. But aside from that far-fetched situation, it seems harmful to limit compensation... especially if it's true that patient compensation is a small part of overall cost. Perhaps if every trial doubled compensation to 10% of today's overall costs, absolute overall costs would decrease because less effort has to go into patient recruitment. I do see one real-world issue with high compensation, but it has nothing to do with ethics. It has to do with statistical interpretation. If you start dangling too much money to participate in a trial, you may change the kind of people who participate in the trial. These individuals might not be representative of the actual users of the drug. The problem is similar to running a drug trial in the US versus Japan. The US has a pretty diverse population with respect to genetics. Japan, in contrast, is almost entirely ethnic Japanese. If you were to somehow succeed in using Japanese trial data to market an acne cream in the US, the same drug that cleared up Japanese faces might result in Venezuelans having their noses fall off! However, I'm cautiously optimistic that higher compensation could make trials more representative. In my mind, I could see how African-Americans, who tend to participate in trials at a lower rate than their Caucasian fellow humans, would, if only for the shameful history of the Tuskegee Syphilis Study, require greater compensation to take the risk of participating in a trial. |
It just seems unfair to subjects to me. Not to mention paternalistic. Every other actor in the process gets enriched based on (limitless it seems) market rates for their contribution, except for the subjects who take on all the risk.