Niyibizi Nyiramugisha, McClary Tekiah, Dixon Margie, Liao April, Speight Candace D, Lang Ayannah, Dickert Neal W, Pentz Rebecca D
Georgia Clinical and Translational Science Alliance at Emory University School of Medicine, Atlanta, GA, USA.
Department of Hematology/Oncology, Winship Cancer Institute of Emory School of Medicine, Atlanta, GA, USA.
AJOB Empir Bioeth. 2025 Jul 3:1-8. doi: 10.1080/23294515.2025.2526325.
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.
医学治疗的临床试验对于医疗进步至关重要且成本高昂。有时，研究药物的费用不在保险或申办方的覆盖范围内，试验参与者需承担这些费用。试验中的参与者费用在伦理上存在争议；审查委员会必须决定是否批准这些试验以及如何处理费用问题。由于对参与者如何看待这些费用知之甚少，我们评估了患者对于在临床试验中被要求支付药物费用的看法。
我们采访了从肿瘤学和心脏病学诊所招募的33名患者。访谈包括两个涉及费用的试验假设情景：（1）两种当前药物的随机试验，自付费用适中但不同；（2）一项涉及更昂贵研究药物的试验。患者被要求分享他们的反应、担忧、对于被邀请参与的偏好，以及如果因安全问题被排除在试验之外应该如何处理。
患者表达了与被要求承担试验费用相关的各种担忧和期望，以及降低研究参与者费用的建议。担忧包括研究药物费用、要求研究参与者承担研究费用的公平性，以及弱势群体可能被排除在外。尽管有这些担忧，患者在允许患者决定是否参与方面优先考虑自主性，认为应该允许“付费参与”试验的发生，并认为试验干预的潜在益处以及个人财务状况将推动参与决策。
尽管对于被要求支付研究药物费用有不同反应，但大多数患者认为不应阻止人们选择参与，因此这些试验不应被禁止。持续了解患者对研究参与及相关费用的看法可以指导审查委员会和研究人员如何处理这些试验。
