Clinical trialist perspectives on the ethics of adaptive clinical trials: a mixed-methods analysis.
Clinical trialist perspectives on the ethics of adaptive clinical trials: a mixed-methods analysis.
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DOI：
10.1186/s12910-015-0022-z
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发表时间：
2015-05-03
影响因子：
2.7
通讯作者：
Fetters MD
中科院分区：
文献类型：
--
作者：
Legocki LJ;Meurer WJ;Frederiksen S;Lewis RJ;Durkalski VL;Berry DA;Barsan WG;Fetters MD
在适应性临床试验（ACT）中，关键的试验特征可以在试验过程中根据预定义的规则改变，以响应在试验本身内积累的信息。除了具有独特的科学特征外，适应性试验还可能涉及与更传统的随机试验不同的伦理考虑。更好地了解临床试验专家对适应性设计伦理方面的观点可以帮助那些计划ACT的人。我们的目的是阐明临床试验专家对ACT伦理方面的看法。我们使用了一个收敛的，混合方法的设计，采用了22个项目的ACTs信念调查与视觉模拟量表和开放式问题和小型焦点小组。我们开发了一个编码方案，进行专题搜索的文本数据，描述了响应视觉模拟规模的箱线图，并整合调查结果的主题。来自四个组成组的53名临床试验专家参加了研究：学术生物统计学家（n = 5）;顾问生物统计学家（n = 6）;学术临床医生（n = 22）;以及其他利益相关者，包括患者倡导者，美国国立卫生研究院和美国食品药品监督管理局代表（n = 20）。受访者认识到ACT的潜在伦理益处，包括参与者接受有效干预的可能性更高，优化资源利用，加速治疗发现。提出的伦理挑战包括制定程序，使试验参与者能够就参加ACT做出明智的决定，以及研究人员改变招募模式的合理风险。临床试验专家认识到ACT的伦理优势，但也提出了潜在的伦理挑战。这四个选区根据其专业Vantage，在衡量ACT道德考虑方面有所不同。这些数据表明，需要进一步讨论ACT的伦理问题，以促进ACT的规划、设计和实施，并最终使规划者能够更好地权衡竞争性试验设计的伦理影响。本文的在线版本（doi：10.1186/s12910-015-0022-z）包含补充材料，可供授权用户使用。
In an adaptive clinical trial (ACT), key trial characteristics may be altered during the course of the trial according to predefined rules in response to information that accumulates within the trial itself. In addition to having distinguishing scientific features, adaptive trials also may involve ethical considerations that differ from more traditional randomized trials. Better understanding of clinical trial experts’ views about the ethical aspects of adaptive designs could assist those planning ACTs. Our aim was to elucidate the opinions of clinical trial experts regarding their beliefs about ethical aspects of ACTs. We used a convergent, mixed-methods design employing a 22-item ACTs beliefs survey with visual analog scales and open-ended questions and mini-focus groups. We developed a coding scheme to conduct thematic searches of textual data, depicted responses to visual analog scales on box-plot diagrams, and integrated findings thematically. Fifty-three clinical trial experts from four constituent groups participated: academic biostatisticians (n = 5); consultant biostatisticians (n = 6); academic clinicians (n = 22); and other stakeholders including patient advocacy, National Institutes of Health, and U.S. Food and Drug Administration representatives (n = 20). The respondents recognized potential ethical benefits of ACTs, including a higher probability of receiving an effective intervention for participants, optimizing resource utilization, and accelerating treatment discovery. Ethical challenges voiced include developing procedures so trial participants can make informed decisions about taking part in ACTs and plausible, though unlikely risks of research personnel altering enrollment patterns. Clinical trial experts recognize ethical advantages but also pose potential ethical challenges of ACTs. The four constituencies differ in their weighing of ACT ethical considerations based on their professional vantage points. These data suggest further discussion about the ethics of ACTs is needed to facilitate ACT planning, design and conduct, and ultimately better allow planners to weigh ethical implications of competing trial designs. The online version of this article (doi:10.1186/s12910-015-0022-z) contains supplementary material, which is available to authorized users.
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影响因子：
2.2
作者：
Saxman, Scott Brian
通讯作者：
Saxman, Scott Brian
影响因子：
1.1
作者：
Gallo, Paul;Chuang-Stein, Christy;Pinheiro, Jose
通讯作者：
Pinheiro, Jose
影响因子：
11.2
作者：
Perlmutter, Jane;Bell, Shannon K.;Darien, Gwen
通讯作者：
Darien, Gwen
影响因子：
8.3
作者：
Tehranisa, Jason S.;Meurer, William J.
通讯作者：
Meurer, William J.
DOI：
10.1177/1740774514563583
发表时间：
2015-04-01
期刊：
Clinical trials (London, England)
影响因子：
--
作者：
Hey, Spencer Phillips;Kimmelman, Jonathan
通讯作者：
Kimmelman, Jonathan