Researchers from the Perelman School of Medicine, Leonard Davis Institute of Health Economics, University of Pennsylvania, argue that rejecting completion bonuses entirely is unnecessary, and fails to address the challenges to patient retention, in a paper recently published in Sage Journals’ Clinical Trials.
To further discuss their case, Outsourcing-Pharma (OSP) talked with co-author Emily Largent, JD, PhD, RN (EL), an assistant professor of medical ethics and health policy at the Perelman School of Medicine, University of Pennsylvania.
OSP: How must the industry address the ethical problems associated with participant attrition?
EL: There are a number of ways that we might address attrition – one of the most important is to design trials with participant input to make them as convenient and appealing as possible.
That said, as a result of scientific and methodological considerations, trials may often still include some elements that are less desirable to participants. That’s when completion bonuses can be helpful.
Completion bonuses are a means of incentivizing participants to remain in a trial until they reach pre-specified checkpoints or endpoints within a trial by making receipt of the bonus conditional on staying in the study. At that point, their data is most valuable to the investigators.
OSP: What position do regulators currently take on the use of completion bonuses?
EL: The regulations do not address payment broadly or completion bonuses specifically. That said, any payment needs to comply with the regulatory requirement to minimize the possibility of coercion or undue influence.
In my experience, IRBs are quite cautious about offering completion bonuses.
OSP: Why do completion bonuses remain ethically controversial?
EL: In research, we talk about the importance of participants having the right to withdraw without penalty at any time — this reflects the importance of voluntary informed consent. And completion bonuses are specifically designed to get people not to exercise their right to withdraw.
OSP: How is a completion bonus different from other incentive payments?
EL: All completion bonuses are incentives, but not all incentives are completion bonuses.
Completion bonuses are distinct because of their timing, their conditional nature, and the intent to induce participants to remain in a study until they reach a pre-specified endpoint.
OSP: For what reasons do you argue that completion bonuses are never coercive?
EL: Completion bonuses are a conditional promise: If you reach this pre-specified study endpoint, then the money is yours. Coercion occurs when someone is threatened with harm, and they have no reasonable alternative but to comply.
If a participant decides to withdraw from a study prior to reaching one of these endpoints, then he or she doesn’t satisfy the conditions to receive the completion bonus.
The investigator is under no obligation to pay and isn’t coercing the participant; rather, the investigator is merely enforcing the terms of the original agreement. There’s no threat of harm.
OSP: What safeguards must be in place to ensure such bonuses do not encourage unreasonable continued participation in a study?
Well-functioning IRB review is really important in this context. Additionally, the pre-specified study endpoints should include not only completion of the planned study therapy, but also the occurrence of any serious adverse event or circumstance that would lead people to conclude that continued participation is unreasonable.
Participants should be reimbursed for expenses and be compensated so that they don’t feel like they have to stay in (i.e., get the completion bonus) to be fairly compensated. And, it may be helpful, to restrict the bonus amount.
Source: Sage Journals: Clinical Trials
Making the case for completion bonuses in clinical trials
Authors: Emily A Largent, Holly Fernandez Lynch
