Subjects' Views of Obligations to Ensure Post-Trial Access to Drugs, Care, and Information: Qualitative Results from the Experiences of Participants in Clinical Trials (EPIC) Study

There is increasing interest in the question of what, if anything, research subjects are owed after their participation in a clinical trial ends. This article reports on 93 individuals who participated in 10 focus groups. Many participants thought researchers, sponsors, health insurers, and others should facilitate access to the drug, or a therapeutic equivalent after the trial has ended, if the drug benefited the subject. Some thought these groups should also provide transition care (referrals to nontrial physicians or other trials, limited followup, short-term drug supply) or care for long-term adverse events. In contrast, other participants felt these groups had no obligations regarding drugs or care. Participants generally agreed that subjects should receive information (drug name, dosage received, market approval date, long-term adverse effects, and results after a trial has ended). They cited health need, cost, relationships, reciprocity, free choice, and sponsor self-interest to support their views, and many of their reasons overlapped with those commonly discussed by bioethicists.