Clinical Research Payments: A Case for Change

1 week ago 0

In 2002, San Francisco voters approved the ‘Care Not Cash’ policy, aiming to stop distributing money to homeless individuals on the assumption they would misuse it on drugs and alcohol. This approach contrasted sharply with practices in addiction research. In studies, participants using drugs were often compensated in cash, challenging the idea that such payments encouraged relapse.

Research outcomes showed a different reality: participants primarily spent their earnings on essential expenses like rent, food, and bills rather than on drugs. This financial aid facilitated the development of new treatments by allowing individuals to engage in studies, covering costs of time, travel, and support required to participate.

Currently, the federal government is reconsidering the legality of payments to participants in clinical trials. The Office of Inspector General has called for public comments on whether to formalize protections for these payments, with submissions due by August 24. Though payments have operated in a legal gray area due to anti-kickback laws and regulations discouraging incentives for Medicare and Medicaid recipients, the discussion is essential for supporting American clinical research.

The main concern lies in the perception of reimbursing federal beneficiaries’ costs as inducements to use services. Bioethical worries suggest money might influence decisions, especially among vulnerable populations.

Studies examining the impact of cash payments on drug users found they did not increase drug usage or lead to coerced consent. Instead, payments improved study follow-up rates. Participants generally dismissed the notion that research funding swayed their decision to join studies.

A notable study in 2021 evaluated randomized cash incentives within clinical trials. These incentives boosted enrollment in one trial while remaining neutral in another, without distorting risk assessment or participant demographics.

Justice and scientific integrity suggest that proceeding with trials involving low-income Medicaid participants or actively using drugs enhances relevance and reliability. It’s pivotal for developing treatments suitable for these groups, as demonstrated by Suboxone’s success. Denying adequate compensation risks excluding or exploiting those most affected and who require treatment solutions.

The inspector general should consider two main aspects when establishing rules:

Reimbursement for actual out-of-pocket costs: Restores financial standing and should be straightforward. In 2018, FDA deemed travel and lodging reimbursements acceptable regarding undue influence concerns.
Compensation for time: Complexities should be managed by institutional review boards. Avoid fixed dollar caps because adequate compensation depends on study demands.

Protections should include academic and industry trials, given their significant role in research. Review boards are tasked with assessing fair payment and participant safety, which should continue.

The ‘Care Not Cash’ initiative presumed some individuals would misuse money, while clinical trials revealed the opposite. Involved participants helped prove that buprenorphine-naloxone worked as intended, contributing to Suboxone’s lifesaving successes.

The participation in clinical trials is a form of work. It requires adherence to protocol, punctuality, and sometimes facing physical risks. Medicaid’s work requirements should encompass efforts that combat diseases trapping individuals in poverty. The inspector general has the opportunity to institutionalize these insights into formal regulations, favoring evidence over outdated fears.

Matthew Baggott, Ph.D., is the CEO of Tactogen Inc. John Mendelson, M.D., is an internist specializing in addiction treatment and serves as Chief Medical Officer at Ria Health.