Patients’ views on paying to participate in clinical trials.
Authors: Niyibizi Nyiramugisha , McClary Tekiah , Dixon Margie D. , Liao April , Speight Candace , Lang Ayannah , Dickert Neal W. , Pentz Rebecca D. 
Published: June 2023

e13614

Background: Clinical trials are critical to development of drugs for cancers and other conditions. Sometimes investigational drugs are not covered by insurance or sponsors and trial participants are asked to bear costs. Review boards must decide whether to approve these trials and how costs should be presented. We evaluated patients’ views about being asked to pay for investigational drugs. Methods: Thirty patients were interviewed: 15 cancer patients approached at an infusion center, and 15 cardiology patients approached in clinic or selected among patients who had authorized research contact. Interviews contained two hypothetical scenarios of clinical trials; one randomized trial comparing two standard of care drugs at $5 or $100/month, and another trial of a novel drug at $1000/month. Participants were asked whether they thought trials like these should be allowed to occur, how they would want to be approached, what should happen if removed due to safety concerns, and what other concerns they had. Results: For the hypothetical trial comparing two drugs, 11 participants (37%) stated they would be willing to enroll and pay the cost of the drug. Motivations by those willing to enroll were the opportunity for another treatment option (2/11), hoping to receive a life-saving medication for a severe condition (4/11), and having the financial ability to pay costs associated with the trial (4/11). Regardless of willingness to enroll in this trial, 17 (57%) participants explicitly stated concerns about costs, 25 (83%) mentioned a concern about side effects or efficacy of the medications, and 11 (37%) felt that trial participants would bear a greater burden and receive less benefit than the trial sponsors. For the $1000/month trial, six participants (20%) were willing to enroll and pay the costs. Participants cited motivations for enrolling as exposure to new treatment options (2/6), hoping to receive a life-saving treatment for a severe condition (4/6), and being financially stable enough to afford the costs (2/6). Concerns among respondents included the cost of the medication (25, 83%), the efficacy or side effects of this new drug (15, 50%), and unequal benefits to participants compared to trial sponsors (6, 20%). Although not all participants were willing to enroll in these trials, 24 (80%) stated that they should still be allowed to happen, because there are people willing to pay the costs; only one participant explicitly stated that these types of trials should not happen at all. Conclusions: Patients were not offended by being asked to pay to participate in clinical trials, despite having concerns about costs and the medications. Regardless of personal willingness to enroll, most respondents thought participants should have the freedom to choose whether to participate. There is a need for continued understanding of patient views of research involving direct costs, but these data suggest that patients would not support outright prohibition of cost-sharing.