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整合随机对照试验与真实世界数据分析的协同效应。

Synergies From Integrating Randomized Controlled Trials and Real-World Data Analyses.

作者信息

Najafzadeh Mehdi, Gagne Joshua J, Schneeweiss Sebastian

机构信息

Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.

出版信息

Clin Pharmacol Ther. 2017 Dec;102(6):914-916. doi: 10.1002/cpt.873. Epub 2017 Oct 16.

DOI:10.1002/cpt.873
PMID:29034448
Abstract

Analyses using administrative claims databases or national registries provide estimates of benefits and harms of medications in real-world settings for large and diverse patient populations. Whereas claims-based nonrandomized studies and randomized-controlled trials (RCTs) have distinct limitations, their strengths are complementary. Integrating RCT and claims data offers substantial synergies. We propose obtaining routinely collected longitudinal claims data from RCT participants and discuss the added value of the novel evidence that can be derived from this "information overlap."

摘要

使用行政索赔数据库或国家登记处进行的分析,可为大量不同患者群体在现实环境中使用药物的益处和危害提供估计。基于索赔的非随机研究和随机对照试验(RCT)虽有明显局限性,但其优势具有互补性。整合RCT和索赔数据可产生巨大协同效应。我们建议从RCT参与者那里获取常规收集的纵向索赔数据,并讨论可从这种“信息重叠”中得出的新证据的附加价值。

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