Exploring the ethical and regulatory issues in pragmatic clinical trials.
Exploring the ethical and regulatory issues in pragmatic clinical trials.
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DOI：
10.1177/1740774515598334
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发表时间：
2015-10
期刊：
影响因子：
--
通讯作者：
Sugarman J
中科院分区：
文献类型：
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作者：
Califf RM;Sugarman J
需要高质量的证据来支持患者，医生，护理提供者，政策制定者关于健康和医疗保健的决策是有据可查的。然而，证据方面的严重缺陷依然存在。实用的临床试验（PCT），使用新的技术和新兴的信息和通信技术，以探索重要的研究问题迅速和成本的一小部分，由更“传统”的研究方法承诺，以帮助缩小这一差距。然而，虽然多氯三联苯可以连接临床实践和研究，但它们也可能带来困难的伦理和监管挑战。在这篇文章中，作者简要地调查了目前的证据状况，这些证据可用于为临床护理和其他健康相关决策提供信息，并讨论了PCT改善当前状况的潜力。然后，他们提出了一个新的工作定义，为务实的研究，中心健身，为有关健康和医疗保健的决策提供信息。最后，他们介绍了一个由美国国立卫生研究院（NIH）卫生保健系统研究合作实验室和国家以患者为中心的临床研究网络（PCORnet）联合开展的项目，该项目解决了当前临床研究监管和伦理监督系统的11个关键方面，这些系统对进行PCT构成了挑战。在本期《临床试验》中关于这一主题的系列文章中，每个方面都有自己的专门文章，特别关注伦理和监管考虑因素与务实的临床研究之间的相互作用，这些临床研究利用创新设计和新技术和网络来告知有关健康和医疗保健的“现实世界”选择。
The need for high-quality evidence to support decision-making about health and health care by patients, physicians, care providers, policymakers is well documented. However, serious shortcomings in evidence persist. Pragmatic clinical trials (PCTs) that use novel techniques and emerging information and communication technologies to explore important research questions rapidly and at a fraction of the cost incurred by more “traditional” research methods promise to help close this gap. Nevertheless, while PCTs can bridge clinical practice and research, they may also raise difficult ethical and regulatory challenges. In this article, the authors briefly survey the current state of evidence that is available to inform clinical care and other health-related decisions and discuss the potential for PCTs to improve the current state of affairs. They then propose a new working definition for pragmatic research that centers upon fitness for informing decisions about health and health care. Finally, they introduce a project, jointly undertaken by the National Institutes of Health (NIH) Health Care Systems Research Collaboratory and the National Patient-Centered Clinical Research Network (PCORnet), which addresses 11 key aspects of current systems for regulatory and ethical oversight of clinical research that pose challenges to conducting PCTs. In the series of articles commissioned on this topic in the current issue of Clinical Trials, each of these aspects receives its own dedicated article, with a special focus on the interplay between ethical and regulatory considerations and pragmatic clinical research that leverages innovative designs and new technologies and networks to inform “real-world” choices about health and health care.