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1
Electronic healthcare databases in Europe: descriptive analysis of characteristics and potential for use in medicines regulation.欧洲的电子医疗保健数据库：特征描述及在药品监管中的应用潜力分析
BMJ Open. 2018 Sep 5;8(9):e023090. doi: 10.1136/bmjopen-2018-023090.
2
Data Rich, Information Poor: Can We Use Electronic Health Records to Create a Learning Healthcare System for Pharmaceuticals?数据丰富，信息匮乏：我们能否利用电子健康记录为制药行业创建学习型医疗保健系统？
Clin Pharmacol Ther. 2019 Apr;105(4):912-922. doi: 10.1002/cpt.1226. Epub 2018 Oct 14.
3
The use of real-world data in cancer drug development.真实世界数据在癌症药物研发中的应用。
Eur J Cancer. 2018 Sep;101:69-76. doi: 10.1016/j.ejca.2018.06.036. Epub 2018 Jul 18.
4
Study Design and Evaluation of Risk Minimization Measures: A Review of Studies Submitted to the European Medicines Agency for Cardiovascular, Endocrinology, and Metabolic Drugs.研究设计和风险最小化措施评估：对向欧洲药品管理局提交的心血管、内分泌和代谢药物研究的综述。
Drug Saf. 2018 Feb;41(2):191-202. doi: 10.1007/s40264-017-0604-4.
5
Measuring the impact of medicines regulatory interventions - Systematic review and methodological considerations.衡量药品监管干预措施的影响——系统评价及方法学考虑。
Br J Clin Pharmacol. 2018 Mar;84(3):419-433. doi: 10.1111/bcp.13469. Epub 2017 Dec 20.
6
Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0.报告以提高医疗保健数据库研究的可重复性并促进有效性评估V1.0版
Pharmacoepidemiol Drug Saf. 2017 Sep;26(9):1018-1032. doi: 10.1002/pds.4295.
7
Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works.促进和保护公众健康：欧盟药物警戒系统如何运作
Drug Saf. 2017 Oct;40(10):855-869. doi: 10.1007/s40264-017-0572-8.
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Monitoring safety in a phase III real-world effectiveness trial: use of novel methodology in the Salford Lung Study.在一项III期真实世界有效性试验中监测安全性：索尔福德肺部研究中新型方法的应用。
Pharmacoepidemiol Drug Saf. 2017 Mar;26(3):344-352. doi: 10.1002/pds.4118. Epub 2016 Nov 1.
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ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions.ROBINS-I：一种评估干预性非随机研究偏倚风险的工具。
BMJ. 2016 Oct 12;355:i4919. doi: 10.1136/bmj.i4919.
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Multi-centre, multi-database studies with common protocols: lessons learnt from the IMI PROTECT project.采用通用方案的多中心、多数据库研究：从IMI PROTECT项目中汲取的经验教训。
Pharmacoepidemiol Drug Saf. 2016 Mar;25 Suppl 1:156-65. doi: 10.1002/pds.3968.

Real-World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe.

作者信息

Cave Alison, Kurz Xavier, Arlett Peter

机构信息

Pharmacovigilance and Epidemiology Department, European Medicines Agency, Amsterdam, The Netherlands.

出版信息

Clin Pharmacol Ther. 2019 Jul;106(1):36-39. doi: 10.1002/cpt.1426. Epub 2019 Apr 10.

DOI:10.1002/cpt.1426
PMID:30970161
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6617710/
Abstract
摘要