Patients' Views on Paying to Participate in Clinical Trials

Clinical trials of medical therapies are critical for the advancement of care and are expensive. Sometimes, the costs of study drugs are not covered by insurance or the sponsor, and trial participants bear the costs. Participant costs in trials have been ethically controversial; review boards must decide whether to approve these trials and how to address costs. Because little is known about how participants view these costs, we evaluated patients' perspectives about being asked to pay for drugs in a clinical trial.

We interviewed 33 patients recruited from oncology and cardiology clinics. Interviews included two hypothetical scenarios of trials involving costs: (1) a randomized trial of two current medications with moderate but different out-of-pocket costs; and (2) a trial involving a more expensive investigational drug. Patients were asked to share reactions, concerns, preferences about being approached, and what should happen if removed from the trial due to safety concerns.

Patients expressed a variety of concerns and expectations associated with being asked to bear trial costs, as well as suggestions to reduce costs to research participants. Concerns included the study drug expense, fairness of asking research participants to bear study costs, and that disadvantaged individuals could be excluded. Despite sharing these concerns, patients prioritized autonomy in allowing patients to decide whether to participate, felt that "pay-to-participate" trials should be allowed to occur, and thought potential benefits from trial interventions, along with personal financial situation, would drive participation decisions.

Despite mixed reactions about being asked to pay for study drugs, the majority of patients felt that people should not be prevented from having the option to participate and thus that these trials should not be prohibited. Continued understanding of patient views of research participation and the costs involved can guide how review boards and researchers address these trials.