The general, practice research database - Role in pharmacovigilance

The general, practice research database - Role in pharmacovigilance
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DOI:
10.2165/00002018-200427120-00004
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发表时间:
2004-01-01
期刊:
影响因子:
4.2
通讯作者:
Martinez, C
Martinez, C
中科院分区:
医学2区
文献类型:
--
作者:
Wood, L;Martinez, C

文献摘要

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全科医学研究数据库(GPRD)是世界上最大的匿名纵向临床记录的计算机化数据库。该数据库在药物安全性信号评估领域享有国际声誉,基于GPRD的药物流行病学研究结果已用于为监管药物警戒决策提供信息。数据的特点和丰富性使得GPRD很可能成为风险管理和药物警戒计划中预期的主动药物警戒的关键数据源。文章介绍了数据库的最新发展和从中获得的新数据-包括自发记录的疑似药物不良反应-的更新,并描述了如何使用数据来支持各种药物警戒应用。还讨论了在未来的信号检测和药物警戒活动的影响评估中使用GPRD的可能性。
The General Practice Research Database (GPRD) is the world's largest computerised database of anonymised longitudinal clinical records from primary care. The database already has an international reputation in the field of drug safety signal evaluation where the results of GPRD-based pharmacoepidemiological studies have been used to inform regulatory pharmacovigilance decision making., The characteristics and richness of the data are such that the GPRD is likely to prove a key data resource for the proactive pharmacovigilance anticipated in risk management and pharmacovigilance plans.An update of recent developments to the database and new data available from it - including spontaneously recorded suspected adverse drug reactions - is presented in the article, with a description of how the data can be used to support a variety of pharmacovigilance applications. The possibility of using the GPRD in signal detection and assessment of the impact of pharmacovigilance activities in the future is also discussed.