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.
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.
复制标题
受试者对确保对药物的审判访问，护理和信息的义务的看法：来自临床试验参与者的经验（EPIC）研究的定性结果。
DOI：
10.1136/jme.2008.024711
复制
发表时间：
2009-03
影响因子：
4.1
通讯作者：
Weissman JS
中科院分区：
文献类型：
--
作者：
Sofaer N;Thiessen C;Goold SD;Ballou J;Getz KA;Koski G;Krueger RA;Weissman JS
报告美国临床试验中受试者关于他们是否以及为什么应该获得试验药物、护理和信息的试验后访问(PTA)的态度和意见。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。目前和最近正在进行临床试验的受试者，主要是慢性疾病。93人参加了10个焦点小组。许多人认为，研究人员、赞助商、健康保险公司和其他人共同承担义务，促进对试验药物的PTA，如果它对受试者有利，或对治疗等价物。一些人认为PTA的义务包括提供过渡性护理(转诊到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。相反，其他人则认为，在药物或护理方面没有PTA义务。然而，双方一致认为，以前的受试者应该得到信息(药物名称、接受的剂量、上市批准日期、长期不良反应、试验结果)。参与者经常呼吁健康需求、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。在美国的慢性病试验中，许多参与者认为有义务促进以“公平”的价格对试验药物进行PTA；与其他研究中的非美国受试者相比，这些观点要求较低。然而，我们的参与者对信息义务的看法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的辩论应该超越试验药物和汇总结果。
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. Ninety-three individuals participated in ten 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.
登录
查看更多内容
影响因子：
8.8
作者：
Pace, C;Miller, FG;Danis, M
通讯作者：
Danis, M
影响因子：
2.1
作者：
Miller, Paul B.;Weijer, Charles
通讯作者：
Weijer, Charles
影响因子：
2.3
作者：
APPELBAUM, PS;ROTH, LH;LIDZ, C
通讯作者：
LIDZ, C
DOI：
10.1080/08989629908573939
发表时间：
1999-01-01
期刊：
Accountability in research
影响因子：
--
作者：
Lemmens, Trudo;Elliott, Carl
通讯作者：
Elliott, Carl
影响因子：
3.3
作者：
Glantz, LH;Annas, GJ;Mariner, WK
通讯作者：
Mariner, WK