The Impact of Clinical Trial Payments on Drug Use and Research Participation

In 2002, voters in San Francisco supported the “Care Not Cash” initiative, which aimed to stop handing cash to homeless individuals due to concerns that the money would be wasted on substances like drugs and alcohol. This contrasted sharply with practices in clinical research, where payment to participants using drugs was routine.

The conventional belief was that funding participants in drug research encouraged relapse; however, studies revealed that most money was spent on necessities like rent, food, and bills rather than drugs. Participation in trials, like those testing the buprenorphine and naloxone combination, known as Suboxone, requires time, travel, and support. Without financial compensation, individuals might not afford to participate.

Currently, the Department of Health and Human Services (HHS) Office of Inspector General seeks public comment on protecting payments in clinical trials, specifically focusing on federal beneficiaries potentially induced to use reimbursable services. Historical tensions came from an anti-kickback statute and regulations discouraging inducements.

“Bioethical concerns consider whether monetary compensation could corrupt choices, especially among vulnerable individuals using drugs.”

Research shows payment in clinical trials doesn’t increase drug use or coerce participants but improves follow-up rates. When asked if money influenced their participation, most rejected the idea, noting they could procure drugs independently of trial payments. Evidence suggests higher payments increase attention to risk disclosures.

In 2021, randomized cash incentives inside clinical trials showed increased enrollment without altering risk assessments or samples skewing toward poorer participants. Effective treatments largely depend on trials that include the very populations they aim to treat. Excluding or underpaying these individuals undermines research efforts and exploits them financially.

The inspector general is encouraged to codify reimbursement for participants’ out-of-pocket expenses, as clarified by the FDA in 2018 regarding travel and lodging costs. The complexity of compensation for time necessitates leaving decisions to institutional review boards without applying strict dollar caps, a practice that could either constrain study designs or exclude vital participants.

Clinical trial involvement is akin to work: adhering to protocols, punctual attendance, and occasionally, taking on physical risks. With Medicaid’s work requirements, participation in trials that help alleviate poverty-related diseases should qualify as work activity.

Dr. Matthew Baggott, a neuroscientist and CEO of Tactogen Inc., and Dr. John Mendelson, an experienced internist focused on addiction treatment, argue that clinical trials have demonstrated trust capabilities contrary to assumptions in “Care Not Cash.” These trials enabled the development of Suboxone, saving many lives, showcasing a crucial lesson for policy consideration.