Sofaer N, Thiessen C, Goold S D, Ballou J, Getz K A, Koski G, Krueger R A, Weissman J S
Harvard University, Boston, Massachusetts, USA.
J Med Ethics. 2009 Mar;35(3):183-8. doi: 10.1136/jme.2008.024711.
To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and information.
Focus groups, short self-administered questionnaires.
Boston, Dallas, Detroit, Oklahoma City.
Current and recent subjects in clinical trials, primarily for chronic diseases.
93 individuals participated in 10 focus groups. Many thought researchers, sponsors, health insurers and others share obligations to facilitate PTA to the trial drug, if it benefited the subject, or to a therapeutic equivalent. Some thought PTA obligations include providing transition care (referrals to non-trial physicians or other trials, limited follow-up, short-term drug supply) or care for long-term adverse events. Others held, in contrast, that there are no PTA obligations regarding drugs or care. However, there was agreement that former subjects should receive information (drug name, dosage received, market approval date, long-term adverse effects, trial results). Participants frequently appealed to health need, cost, relationships, reciprocity, free choice and sponsor self-interest to support their views. Many of their reasons overlapped with those commonly discussed by bioethicists.
Many participants in US trials for chronic conditions thought there are obligations to facilitate PTA to the trial drug at a "fair" price; these views were less demanding than those of non-US subjects in other studies. However, our participants' views about informational obligations were broader than those of other subjects and many bioethicists. Our results suggest that the PTA debate should expand beyond the trial drug and aggregate results.
报告美国临床试验受试者对于是否应获得试验药物、护理及信息的试验后获取（PTA）以及原因的态度和观点。
焦点小组、简短的自填式问卷。
波士顿、达拉斯、底特律、俄克拉何马城。
临床试验的当前及近期受试者，主要针对慢性病。
93人参与了10个焦点小组。许多人认为，如果试验药物对受试者有益，研究人员、赞助商、健康保险公司及其他各方有共同义务促进受试者获得试验药物，或获得治疗等效物。一些人认为PTA义务包括提供过渡护理（转介给非试验医生或其他试验、有限的随访、短期药物供应）或护理长期不良事件。相比之下，其他人认为在药物或护理方面不存在PTA义务。然而，大家一致认为，以前的受试者应获得信息（药物名称、服用剂量、市场批准日期、长期不良反应、试验结果）。参与者经常诉诸健康需求、成本、关系、互惠、自由选择和赞助商自身利益来支持他们的观点。他们的许多理由与生物伦理学家通常讨论的理由重叠。
美国慢性病试验的许多参与者认为有义务以“公平”价格促进受试者获得试验药物；这些观点的要求低于其他研究中美国以外受试者的观点。然而，我们的参与者在信息义务方面的观点比其他受试者和许多生物伦理学家的观点更广泛。我们的结果表明，PTA的辩论应超越试验药物和汇总结果进行扩展。
