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Authors' Reply to Ravi Jandhyala's Comment on "Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments".

作者信息

McGettigan Patricia, Olmo Carla Alonso, Plueschke Kelly, Castillon Mireia, Zondag Daniel, Bahri Priya, Kurz Xavier, Mol Peter G M

机构信息

William Harvey Research Institute, Queen Mary University of London, Charterhouse Square, London, UK.

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

出版信息

Drug Saf. 2019 Dec;42(12):1517-1518. doi: 10.1007/s40264-019-00863-w.

DOI:10.1007/s40264-019-00863-w
PMID:31552604
Abstract
摘要

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本文引用的文献

1
Comment on: "Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments".评论：《患者登记数据库：药物评估中未充分利用的资源：关于在监管评估中增加使用患者登记数据库的操作建议》
Drug Saf. 2019 Dec;42(12):1515-1516. doi: 10.1007/s40264-019-00862-x.
2
Patient Registries: An Underused Resource for Medicines Evaluation : Operational proposals for increasing the use of patient registries in regulatory assessments.患者登记处：药物评估中未充分利用的资源：提高监管评估中患者登记处使用的操作性建议。
Drug Saf. 2019 Nov;42(11):1343-1351. doi: 10.1007/s40264-019-00848-9.
3
Barriers and Opportunities for Use of Patient Registries in Medicines Regulation.
药品监管中使用患者登记系统的障碍与机遇
Clin Pharmacol Ther. 2019 Jul;106(1):39-42. doi: 10.1002/cpt.1414. Epub 2019 Apr 10.
4
Imposed registries within the European postmarketing surveillance system: Extended analysis and lessons learned for regulators.在欧洲上市后监测系统中实施的注册制度：对监管机构的扩展分析和经验教训。
Pharmacoepidemiol Drug Saf. 2018 Jul;27(7):823-826. doi: 10.1002/pds.4449. Epub 2018 May 11.
5
Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013.欧洲上市后监测中的注册研究：2005-2013 年集中批准产品的回顾性分析。
Pharmacoepidemiol Drug Saf. 2017 Dec;26(12):1442-1450. doi: 10.1002/pds.4196. Epub 2017 Mar 26.
6
Registry-based randomized controlled trials- what are the advantages, challenges, and areas for future research?基于注册登记的随机对照试验——其优势、挑战及未来研究方向有哪些？
J Clin Epidemiol. 2016 Dec;80:16-24. doi: 10.1016/j.jclinepi.2016.08.003. Epub 2016 Aug 20.
7
The randomized registry trial--the next disruptive technology in clinical research?随机注册试验——临床研究中的下一项颠覆性技术？
N Engl J Med. 2013 Oct 24;369(17):1579-81. doi: 10.1056/NEJMp1310102. Epub 2013 Aug 31.
8
Qualitative synthesis and systematic review in health professions education.卫生专业教育中的定性综合与系统评价。
Med Educ. 2013 Mar;47(3):252-60. doi: 10.1111/medu.12092.