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The hope, hype and reality of Big Data for pharmacovigilance.

作者信息

Bate Andrew, Reynolds Robert F, Caubel Patrick

机构信息

Epidemiology, Worldwide Safety, Pfizer R&D, Walton Oaks, England, UK; New York University, New York, NY, USA.

Global Head of Epidemiology, Worldwide Safety, Pfizer R&D, New York, NY, USA.

出版信息

Ther Adv Drug Saf. 2018 Jan;9(1):5-11. doi: 10.1177/2042098617736422. Epub 2017 Oct 31.

DOI:10.1177/2042098617736422
PMID:29318002
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5753994/
Abstract
摘要

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Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making.治疗和/或比较效果的真实世界数据研究的良好实践：ISPOR-ISPE联合特别工作组关于医疗保健决策中真实世界证据的建议。
Pharmacoepidemiol Drug Saf. 2017 Sep;26(9):1033-1039. doi: 10.1002/pds.4297.
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Pharmacoepidemiol Drug Saf. 2017 Sep;26(9):1018-1032. doi: 10.1002/pds.4295.
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Cloudy with a Chance of Pain: Engagement and Subsequent Attrition of Daily Data Entry in a Smartphone Pilot Study Tracking Weather, Disease Severity, and Physical Activity in Patients With Rheumatoid Arthritis.《多云有疼痛风险：类风湿关节炎患者智能手机试点研究中日常数据录入的参与度及后续流失情况，该研究追踪天气、疾病严重程度和身体活动》
JMIR Mhealth Uhealth. 2017 Mar 24;5(3):e37. doi: 10.2196/mhealth.6496.
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Transforming Evidence Generation to Support Health and Health Care Decisions.转化证据生成以支持健康及医疗保健决策。
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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。
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The Rise of Consumer Health Wearables: Promises and Barriers.消费级健康可穿戴设备的崛起：前景与障碍
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Computer-assisted expert case definition in electronic health records.电子健康记录中的计算机辅助专家病例定义
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Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection.自发不良反应报告与电子健康记录在信号检测中的有益相互作用。
Drug Saf. 2015 Dec;38(12):1201-10. doi: 10.1007/s40264-015-0341-5.