Ethics and practice of Trials within Cohorts: An emerging pragmatic trial design
Ethics and practice of Trials within Cohorts: An emerging pragmatic trial design
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DOI：
10.1177/1740774517746620
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发表时间：
2018-02-01
期刊：
影响因子：
2.7
通讯作者：
Relton, Clare
中科院分区：
文献类型：
--
作者：
Kim, Scott Y. H.;Flory, James;Relton, Clare
背景资料：随着对实用性试验的日益重视，新的随机临床试验设计被提出来增强所产生的数据的真实的世界性质。我们描述了一种这样的设计，适用于非盲的实用临床试验，其中对照组接受常规护理，称为队列内试验，由于其招募效率，减轻受试者负担的优势以及更好地模拟真实世界同意过程的能力，在各个国家越来越多地使用。方法：队列内试验设计的描述性，伦理和美国监管分析。队列设计中的试验包括，在招募到队列后，对合格受试者进行随机化，然后对两组进行不对称治疗：选择用于实验组的受试者提供干预试验的知情同意书，而对照组的数据基于事先的广泛许可使用。因此，与传统的Zelen随机化后知情同意设计不同，队列参与者被告知队列内的未来研究;然而，目前这种披露的程度因研究而异。因此，伦理分析提供了两种类型的情况下：当预随机化披露和同意有关嵌入式试验是相当明确和详细的，当他们只包括一般声明，对未来的数据使用。这些不同的伦理情况可能会影响伦理审查委员会如何适用于美国的研究规则有关豁免和变更的知情consense.Conclusion：队列试验是一个有前途的新的务实的随机对照试验设计，正在越来越多地使用在各个国家。虽然实验组与对照组受试者的不对称同意程序最初可能会引起伦理问题，但它在伦理上上级先前的随机化后同意设计，并且与传统试验设计相比具有重要优势。
Background: With increasing emphasis on pragmatic trials, new randomized clinical trial designs are being proposed to enhance the real world nature of the data generated. We describe one such design, appropriate for unmasked pragmatic clinical trials in which the control arm receives usual care, called Trials within Cohorts that is increasingly used in various countries because of its efficiency in recruitment, advantages in reducing subject burden, and ability to better mimic real-world consent processes.Methods: Descriptive, ethical, and US regulatory analysis of the Trials within Cohorts design.Results: Trials within Cohorts design involves, after recruitment into a cohort, randomization of eligible subjects, followed by an asymmetric treatment of the two arms: those selected for the experimental arm provide informed consent for the intervention trial, while the data from the control arm are used based on prior broad permission. Thus, unlike the traditional Zelen post-randomization consent design, the cohort participants are informed about future research within the cohort; however, the extent of this disclosure currently varies among studies. Thus, ethical analysis is provided for two types of situations: when the pre-randomization disclosure and consent regarding the embedded trials are fairly explicit and detailed versus when they consist of only general statements about future data use. These differing ethical situations could have implications for how ethics review committees apply US research rules regarding waivers and alterations of informed consent.Conclusion: Trials within Cohorts is a promising new pragmatic randomized controlled trial design that is being increasingly used in various countries. Although the asymmetric consent procedures for the experimental versus control arm subjects can initially raise ethical concerns, it is ethically superior to previous post-randomization consent designs and can have important advantages over traditional trial designs.