【摘要】：隨著患者、醫(yī)護(hù)人員、藥品注冊(cè)人員和政策決定者對(duì)現(xiàn)實(shí)世界中各種診療手段的安全性和有效性相關(guān)證據(jù)的迫切需求,我們需要新的研究設(shè)計(jì)來(lái)高效有效地對(duì)此類問(wèn)題進(jìn)行評(píng)估。與此同時(shí),越來(lái)越多的二手?jǐn)?shù)據(jù)可以用來(lái)提供此種相關(guān)證據(jù),常用的二手?jǐn)?shù)據(jù)包括電子醫(yī)療檔案和醫(yī)療保險(xiǎn)數(shù)據(jù)等。補(bǔ)充真實(shí)世界數(shù)據(jù)研究同時(shí)利用了現(xiàn)有二手?jǐn)?shù)據(jù)和通過(guò)醫(yī)生/患者收集的一手?jǐn)?shù)據(jù),并將兩者進(jìn)行結(jié)合。在現(xiàn)有數(shù)據(jù)的基礎(chǔ)上,補(bǔ)充真實(shí)世界數(shù)據(jù)研究可以集中精力收集缺失的重要信息來(lái)滿足研究目的。本文將對(duì)補(bǔ)充真實(shí)世界數(shù)據(jù)研究進(jìn)行介紹,包括研究設(shè)計(jì)要素,研究的優(yōu)點(diǎn)和局限性,實(shí)施要點(diǎn)以及應(yīng)用實(shí)例等。
[Abstract]:With patients, health care workers, drug registrants and policy makers in urgent need of evidence about the safety and effectiveness of various diagnostic and therapeutic approaches in the real world, We need new research designs to evaluate such problems efficiently and effectively. At the same time, more and more second-hand data can be used to provide such evidence, such as electronic medical records and medical insurance data. Complementary real-world data use both secondary and primary data collected through doctors / patients and combine the two. Based on the existing data, the research of supplementing real world data can concentrate on collecting missing important information to satisfy the purpose of the research. This paper will introduce the research of supplementary real world data, including the elements of research and design, the advantages and limitations of the research, the main points of implementation and application examples, etc.
【作者單位】： Real-World
【分類號(hào)】：R95

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本文編號(hào)：2218011