A national strategy to develop pragmatic clinical trials infrastructure.
A national strategy to develop pragmatic clinical trials infrastructure.
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DOI：
10.1111/cts.12143
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发表时间：
2014-04
期刊：
影响因子：
--
通讯作者：
Carey TS
中科院分区：
文献类型：
--
作者：
Concannon TW;Guise JM;Dolor RJ;Meissner P;Tunis S;Krishnan JA;Pace WD;Saltz J;Hersh WR;Michener L;Carey TS
比较有效性研究的一个重要挑战是缺乏支持实用临床试验的基础设施，这些临床试验比较通常的实践环境和受试者的干预措施。这些试验提出了与经典疗效试验不同的挑战，经典疗效试验是在理想的情况下、在根据其适合性选择的患者中进行的，并采用高度受控的方案。 2012 年，我们启动了为期一年的学习网络，以确定高度优先的实用临床试验，并通过 NIH 临床和转化科学奖联盟部署可用于启动和维持这些试验的研究基础设施。该网络和基础设施最初是作为对开展实用临床试验感兴趣的研究人员和社区的学习场和共享资源而启动的。我们遵循了开发网络、优先考虑拟议试验和实施学习练习的三个阶段过程，最终在年底举行了为期一天的网络会议。这个为期一年的项目提出了五项建议，涉及发展网络、加强社区参与、应对监管挑战、推进信息技术和开发研究方法。这些建议可在 24 个月内实施，旨在为务实试验建立持续的国家基础设施。
An important challenge in comparative effectiveness research is the lack of infrastructure to support pragmatic clinical trials, which compare interventions in usual practice settings and subjects. These trials present challenges that differ from those of classical efficacy trials, which are conducted under ideal circumstances, in patients selected for their suitability, and with highly controlled protocols. In 2012, we launched a one-year learning network to identify high priority pragmatic clinical trials and to deploy research infrastructure through the NIH Clinical and Translational Science Awards Consortium that could be used to launch and sustain them. The network and infrastructure were initiated as a learning ground and shared resource for investigators and communities interested in developing pragmatic clinical trials. We followed a three-stage process of developing the network, prioritizing proposed trials, and implementing learning exercises that culminated in a one-day network meeting at the end of the year. The year-long project resulted in five recommendations related to developing the network, enhancing community engagement, addressing regulatory challenges, advancing information technology, and developing research methods. The recommendations can be implemented within 24 months and are designed to lead toward a sustained national infrastructure for pragmatic trials.
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