Real world data: an opportunity to supplement existing evidence for the use of long-established medicines in health care decision making
Real world data: an opportunity to supplement existing evidence for the use of long-established medicines in health care decision making
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DOI：
10.2147/jmdh.s160029
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发表时间：
2018-01-01
影响因子：
3.3
通讯作者：
Zou, Kelly H.
中科院分区：
文献类型：
--
作者：
Katkade, Vaibhav B.;Sanders, Kafi N.;Zou, Kelly H.
在现实世界中使用药物的证据可以帮助推断和/或增加在随机对照试验中获得的数据，并建立药物在日常临床实践中所处位置的大致情况。在临床试验环境中，通过补充和补充在狭义(通常是优化的)患者群体中获得的安全性和有效性数据，真实世界证据(RWE)可以为利益相关者提供有关药物在大量、不同类别人群中的安全性和有效性的宝贵信息。RWE正在成为一个可靠的信息来源；然而，通过了解其复杂性并应用最适当的分析工具来提取相关信息，RWE仍有改进现实世界数据(RWD)来源的余地。除了为临床医生提供信息外，RWE还具有满足监管考虑的证据负担的潜力，并可用于批准药物的新适应症。如果RWE要充分发挥其潜力，就需要进一步了解RWD的收集和分析。
Evidence from medication use in the real world setting can help to extrapolate and/ or augment data obtained in randomized controlled trials and establishes a broad picture of a medication's place in everyday clinical practice. By supplementing and complementing safety and efficacy data obtained in a narrowly defined (and often optimized) patient population in the clinical trial setting, real world evidence (RWE) may provide stakeholders with valuable information about the safety and effectiveness of a medication in large, heterogeneous populations. RWE is emerging as a credible information source; however, there is scope for enhancements to real world data (RWD) sources by understanding their complexities and applying the most appropriate analytical tools in order to extract relevant information. In addition to providing information for clinicians, RWE has the potential to meet the burden of evidence for regulatory considerations and may be used in approval of new indications for medications. Further understanding of RWD collection and analysis is needed if RWE is to achieve its full potential.