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[The application of real-world evidence in drug regulatory decision-making].[真实世界证据在药品监管决策中的应用]
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Contribution of Real-World Evidence in European Medicines Agency's Regulatory Decision Making.真实世界证据在欧洲药品管理局监管决策中的贡献。
Clin Pharmacol Ther. 2023 Jan;113(1):135-151. doi: 10.1002/cpt.2766. Epub 2022 Nov 4.

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Effectiveness of Ad26.COV2.S Vaccine vs BNT162b2 Vaccine for COVID-19 Hospitalizations.Ad26.COV2.S 疫苗与 BNT162b2 疫苗对 COVID-19 住院治疗的有效性。
JAMA Netw Open. 2022 Mar 1;5(3):e220868. doi: 10.1001/jamanetworkopen.2022.0868.
2
Factors Affecting Citizen Trust and Public Engagement Relating to the Generation and Use of Real-World Evidence in Healthcare.影响公民信任和公众参与的因素与医疗保健中真实世界证据的产生和使用有关。
Int J Environ Res Public Health. 2022 Feb 1;19(3):1674. doi: 10.3390/ijerph19031674.
3
Myocardial Infarction, Stroke, and Pulmonary Embolism After BNT162b2 mRNA COVID-19 Vaccine in People Aged 75 Years or Older.75 岁及以上人群接种 BNT162b2 mRNA COVID-19 疫苗后的心肌梗死、中风和肺栓塞。
JAMA. 2022 Jan 4;327(1):80-82. doi: 10.1001/jama.2021.21699.
4
The Role of Real-World Evidence in FDA-Approved New Drug and Biologics License Applications.真实世界证据在 FDA 批准新药和生物制品许可申请中的作用。
Clin Pharmacol Ther. 2022 Jan;111(1):135-144. doi: 10.1002/cpt.2474. Epub 2021 Nov 22.
5
Marketing Authorization Applications Made to the European Medicines Agency in 2018-2019: What was the Contribution of Real-World Evidence?2018-2019 年向欧洲药品管理局提交的营销授权申请：真实世界证据的贡献是什么？
Clin Pharmacol Ther. 2022 Jan;111(1):90-97. doi: 10.1002/cpt.2461. Epub 2021 Nov 13.
6
Use of Real-World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018-2019.2018-2019 年在欧洲集中授权药物的药品开发中使用真实世界数据和证据。
Clin Pharmacol Ther. 2022 Jan;111(1):310-320. doi: 10.1002/cpt.2462. Epub 2021 Nov 16.
7
Introduction to real-world evidence studies.真实世界证据研究导论。
Perspect Clin Res. 2021 Jul-Sep;12(3):171-174. doi: 10.4103/picr.picr_62_21. Epub 2021 Jul 7.
8
Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model.在监管决策过程中整合真实世界证据：使用逻辑模型对美国、欧盟和中国的经验进行系统分析。
Front Med (Lausanne). 2021 May 31;8:669509. doi: 10.3389/fmed.2021.669509. eCollection 2021.
9
Methodologic approaches in studies using real-world data (RWD) to measure pediatric safety and effectiveness of vaccines administered to pregnant women: A scoping review.使用真实世界数据（RWD）研究测量孕妇接种疫苗的儿科安全性和有效性的方法学方法：范围综述。
Vaccine. 2021 Jun 29;39(29):3814-3824. doi: 10.1016/j.vaccine.2021.05.071. Epub 2021 Jun 2.
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COVID-19 vaccines surveillance in France: a global response to a major national challenge.法国的新冠疫苗监测：对一项重大国家挑战的全球应对。
Anaesth Crit Care Pain Med. 2021 Jun;40(3):100866. doi: 10.1016/j.accpm.2021.100866. Epub 2021 Apr 22.

Real-world evidence (RWE): A challenge for regulatory agencies discussion of the RWE conference with the network of the european medicine agencies, patients, and experts.

作者信息

Maison Patrick, Zureik Mahmoud, Hivert Virginie, Kjaer Jesper, Khonsari Roman Hossein, Trifirõ Gianluca, Ratignier-Carbonneil Christelle

机构信息

ANSM, Paris, France.

Faculté de Santé, Université Paris-Est Créteil, Créteil, France.

出版信息

Front Pharmacol. 2022 Jul 26;13:969091. doi: 10.3389/fphar.2022.969091. eCollection 2022.

DOI:10.3389/fphar.2022.969091
PMID:35959441
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9360563/
Abstract
摘要