Incentives and payments in pragmatic clinical trials: Scientific, ethical, and policy considerations.
Incentives and payments in pragmatic clinical trials: Scientific, ethical, and policy considerations.
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DOI：
10.1177/17407745211048178
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发表时间：
2021-12
期刊：
影响因子：
--
通讯作者：
Sugarman J
中科院分区：
文献类型：
--
作者：
Garland A;Weinfurt K;Sugarman J
实用临床试验（PCT）越来越多地用于生成有关现实世界的临床干预措施的知识。然而，它们涉及一些独特的道德和监管挑战。在本文中，我们研究了一组相关的问题，激励和其他支付给患者的PCT。尽管解释性试验中与激励和支付相关的许多伦理问题与PCT有关，但务实的特征可能会带来额外的挑战。这些问题包括：奖励和付款可能损害多氯三联苯的科学有效性和社会价值;多氯三联苯使用的数据来源;以及在放弃同意的情况下进行多氯三联苯。根据我们对这些问题的研究，我们提出了一些关于多氯联苯的奖励和支付的初步建议，认识到需要更多的数据和经验来完善它们。
Pragmatic clinical trials (PCTs) are increasingly used to generate knowledge about real-world clinical interventions. However, they involve some distinctive ethical and regulatory challenges. In this paper we examine a set of issues related to incentives and other payments to patients in PCTs. Although many of the ethical concerns related to incentives and payments in explanatory trials pertain to PCTs, 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 PCTs, the sources of data used in PCTs, and when the PCTs are conducted under waivers of consent. Based on our examination of these matters, we offer some preliminary recommendations regarding incentives and payments in PCTs, recognizing that additional data and experiences are needed to refine them.
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影响因子：
5.7
作者：
Bollinger, Juli M.;Geller, Gail;Sugarman, Jeremy
通讯作者：
Sugarman, Jeremy
DOI：
10.2307/3564170
发表时间：
1989-07-01
期刊：
IRB
影响因子：
--
作者：
Ackerman, Terrence F
通讯作者：
Ackerman, Terrence F
影响因子：
4.1
作者：
Bentley, J. P.;Thacker, P. G.
通讯作者：
Thacker, P. G.
DOI：
10.1177/1740774515598334
发表时间：
2015-10
期刊：
Clinical trials (London, England)
影响因子：
--
作者：
Califf RM;Sugarman J
通讯作者：
Sugarman J
影响因子：
13.4
作者：
MacKay, Douglas;Saylor, Katherine Witte
通讯作者：
Saylor, Katherine Witte