实用临床试验中的激励措施和报酬：科学、伦理和政策考量。
Incentives and payments in pragmatic clinical trials: Scientific, ethical, and policy considerations.
机构信息
Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA.
Department of Population Health Sciences, School of Medicine, Duke University, Durham, NC, USA.
出版信息
Clin Trials. 2021 Dec;18(6):699-705. doi: 10.1177/17407745211048178.
Pragmatic clinical trials are increasingly used to generate knowledge about real-world clinical interventions. However, they involve some distinctive ethical and regulatory challenges. In this article, we examine a set of issues related to incentives and other payments to patients in pragmatic clinical trials. Although many of the ethical concerns related to incentives and payments in explanatory trials pertain to pragmatic clinical trials, the pragmatic features may introduce additional challenges. These include those related to the risk of incentives and payments undermining the scientific validity and social value of pragmatic clinical trials, the sources of data used in pragmatic clinical trials, and when the pragmatic clinical trials are conducted under waivers of consent. Based on our examination of these matters, we offer some preliminary recommendations regarding incentives and payments in pragmatic clinical trials, recognizing that additional data and experiences are needed to refine them.
实用临床试验越来越多地被用于生成关于真实世界临床干预措施的知识。然而，它们涉及一些独特的伦理和监管挑战。在本文中，我们研究了与实用临床试验中向患者提供激励措施和其他报酬相关的一系列问题。尽管与解释性试验中激励措施和报酬相关的许多伦理问题也适用于实用临床试验，但实用特征可能会带来额外的挑战。这些挑战包括激励措施和报酬可能破坏实用临床试验的科学有效性和社会价值的风险、实用临床试验中使用的数据来源，以及在知情同意豁免的情况下进行实用临床试验的情况。基于我们对这些问题的审查，我们就实用临床试验中的激励措施和报酬提出了一些初步建议，同时认识到需要更多的数据和经验来完善这些建议。
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