Clinical Trial Participation: Compensation and Trust

In 2002, San Francisco voters approved the “Care Not Cash” measure, aiming to redirect cash from homeless individuals under the assumption they would misuse it. Meanwhile, for over a decade, researchers paid people with drug use histories to participate in studies, sparking concern about funding relapse. However, studies revealed the money often supported basic needs like rent, food, and bills.

Research success relies on the ability of participants to afford time and resources needed for trials. For instance, studies on the buprenorphine and naloxone combination, now sold as Suboxone, included participants actively using heroin. Despite past scrutiny, the federal government is re-evaluating payments to clinical trial participants as part of broader support for American clinical research. The HHS Office of Inspector General is seeking comments on this issue, due by August 24.

Payments to clinical trial participants reside in a legal gray area due to an anti-kickback statute that deters incentivizing Medicare and Medicaid patients. The law worries about costs appearing as inducements for reimbursable services, even if these arise through normal care. Bioethics concerns about financial influence on vulnerable participants also exist.

Concerns have been tested through studies involving people using drugs. Evidence shows that paying them does not boost drug use or coercion feelings, instead aiding follow-up and attentiveness to risk. A 2021 study with randomized cash incentives in two clinical trials indicated incentives can raise enrollment without skewing risk perception or participant income demographics.

Justice and scientific validity indicate the necessity of including people who use drugs, are impoverished, or on Medicaid in trials. Successful treatments depend on trials involving these populations, as with Suboxone. Refusing to pay participants risks shifting research costs onto those it aims to help and biases evidence toward different demographics.

Inspections should codify reimbursement for real costs like travel and lodging, echoing FDA 2018 clarifications. Compensation for participant time is more complex and best decided by individual review boards. The decision should avoid hard dollar caps, which could limit study protocols or exclude key participants. Protections should extend beyond government-funded to academic and industry trials, where most research happens.

“Care Not Cash” reflected distrust in financial responsibility. Clinical trials contradicted this view, proving participants’ reliability and showing the effectiveness of the buprenorphine-naloxone combination in real-world use. The product has subsequently saved many lives.

Clinical trial participation is work requiring adherence to protocols and sometimes confronting physical risks. It should be recognized akin to Medicaid’s work requirements. The inspector general’s decision will either enshrine evidence or old fears into rules. Choosing evidence aligns with research and participant interests.

Matthew Baggott, PhD, is a neuroscientist and CEO of Tactogen Inc. John Mendelson, MD, is a board-certified internist with over 30 years in addiction treatment, serving as Chief Medical Officer and Founder of Ria Health.