Thompson’s piece on “Understanding Financial Conflicts of Interest” raises some interesting questions about conflict of interest in a clinical trial setting. What happens if there is no financial benefit for an investigator? Is that even possible? And is a conflict of interest in a clinical trial setting really a conflict of interest or a matter of informed consent?
Financial benefit in a non-industry sponsored clinical trial setting can be difficult to ascertain. The benefit may be immediate, as in per case funding, or long-term, as in authorship. But neither of those examples present financial benefit in themselves; rather, the potential for future financial benefit. Per case funding is designed to help offset the costs of research. It’s typically funnelled through hospital administration and may eventually appear in the form of financial benefit for the investigator. And authorship could be a boon for the investigator’s career, so there is an attributable benefit there that is difficult to price.
So it would seem as though it is difficult to conceive of a clinical trial setting where there is not at least some sort of benefit to the investigators. Now it’s conceivable that the above benefits along with career pressures could influence investigators to increase enrolment to clinical trials, but their agenda must be pushed through the informed consent process – a malleable situation none-the-less. Eligibility criteria establishes parameters for enrolment, so the final say rests with the patient. But the patient could experience duress or even coercion through the informed consent process, which a declared conflict of interest may not mitigate. It may be the case that conflict of interest in a clinical trial setting can only be fully appreciated in the context of informed consent.