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首页> 外文期刊>Therapeutic advances in drug safety. >How Clinical Practice Research Datalink data are used to support pharmacovigilance
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How Clinical Practice Research Datalink data are used to support pharmacovigilance

机译：如何使用临床实践研究数据链接数据来支持药物检测

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Pharmacovigilance can be defined as the science of monitoring medicines and vaccines after license for use, the purpose of which is to quantify and characterise the safety profile of a medicine, identify previously unknown adverse reactions, inform risk-benefit assessment, and support the development of actions that can be taken to reduce risks, optimise benefits and monitor their effectiveness. This review discusses the Clinical Practice Research Datalink (CPRD), which is the source of the largest research database in the UK with longitudinal, representative primary care data linked to data from other healthcare settings. CPRD supports international pharmacovigilance by providing a large, anonymised representative general population database with comprehensive capture of patient risk factors and outcomes to researchers within academic, regulatory and pharmaceutical organisations. The specific advantages of CPRD data are discussed in the context of the 'six Vs of big data' including volume, velocity, variety, veracity, validity and value. Examples of where CPRD data have been used for pharmacovigilance research and how these have fed into guidelines and policy are discussed.
机译：药物可病式可以定义为监测药物和疫苗的许可证后的使用，其目的是量化和表征药物的安全性剖面，确定以前未知的不良反应，告知风险效益评估，并支持发展可以采取的行动减少风险，优化利益和监测其有效性。本次审查讨论了临床实践研究DataLink（CPRD），这是英国最大的研究数据库的来源，纵向，代表初级护理数据与来自其他医疗保健设置的数据相关联。 CPRD通过为学术，监管和制药组织内的研究人员提供综合捕捉患者危险因素和结果来支持国际药物知识。 CPRD数据的具体优势在包括卷，速度，品种，准确性，有效性和值的“六个大数据”的上下文中讨论。 CPRD数据已被用于药物知识研究以及如何讨论如何进入指导方针和政策的例子。

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