The U.S. Food and Drug Administration (FDA) permits clinical trial sponsors to charge patients to participate in research in “extraordinary circumstances,” but, according to a report published in STAT, an increasing number of trials are including these funding mechanisms in their proposals.
In some cases, sponsors have proposed charging anywhere between $7,000 and $250,000 to enroll patients, said Michele Russell-Einhorn, chief compliance officer for Advarra, the second-largest commercial institutional review board (IRB). There were “serious concerns about how ethical it was to charge people to participate in the research — and whether it was absolutely necessary,” she added.
Some of the ethical concerns raised by these types of clinical trials include whether companies are attempting to profit off of desperate patients and whether enrolling only patients who can afford the exorbitant costs will result in skewed trial data.
Given the “pay-to-play” trend, federal regulators such as the FDA, the National Institutes of Health, and the U.S. Department of Health and Human Services’ (HHS’) Secretary’s Advisory Committee on Human Research Protections (SACHRP), have formed panels to draft recommendations on this type of trial. Committee members also are tasked with evaluating and updating existing resource guides for patients to include information about pay-to-play trials.
While many members of the research community have reservations about these types of clinical trials, some experts do not want to completely discount their value.
“There are some [examples] where we think we don’t want to have a hardline stance that says no, never, this could never be appropriate, because sometimes, we think, in rare circumstances, it could be ethically acceptable to ask for this kind of cost-sharing,” said Holly Fernandez Lynch, a University of Pennsylvania bioethicist who sits on a subcommittee that’s helping draft the recommendations.
SACHRP will not finalize its recommendations, which will provide guidance for researchers, patients, IRBs, and regulatory agencies, until December 2019 or March 2020, at which point they will be delivered to HHS Secretary Alex Azar.