真实世界证据试验在医疗保健决策中的作用不断扩大。
The Expanding Role of Real-World Evidence Trials in Health Care Decision Making.
机构信息
Diabetes Research Institute; Mills-Peninsula Health Services, San Mateo, CA, USA.
出版信息
J Diabetes Sci Technol. 2020 Jan;14(1):174-179. doi: 10.1177/1932296819832653. Epub 2019 Mar 6.
Abstract
Real-world evidence (RWE) is the clinical evidence about benefits or risks of medical products derived from analyzing real world data (RWD), which are data collected through routine clinical practice. This article discusses the advantages and disadvantages of RWE studies, how these studies differ from randomized controlled trials (RCTs), how to overcome barriers to current skepticism about RWE, how FDA is using RWE, how to improve the quality of RWE, and finally the future of RWE trials.
摘要
真实世界证据（RWE）是从分析真实世界数据（RWD）中得出的关于医疗产品的获益或风险的临床证据，这些数据是通过常规临床实践收集的。本文讨论了 RWE 研究的优缺点，这些研究与随机对照试验（RCT）的区别，如何克服当前对 RWE 的怀疑的障碍，FDA 如何利用 RWE，如何提高 RWE 的质量，以及 RWE 试验的未来。
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