Real-World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value.

作者信息

Arlett Peter, Kjaer Jesper, Broich Karl, Cooke Emer

机构信息

European Medicines Agency, Amsterdam, Netherlands.

Danish Medicines Agency, Copenhagen, Denmark.

出版信息

Clin Pharmacol Ther. 2022 Jan;111(1):21-23. doi: 10.1002/cpt.2479. Epub 2021 Nov 19.

DOI:10.1002/cpt.2479

PMID:34797920

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9299492/

Abstract

摘要

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7af1/9299492/85e0552f47bd/CPT-111-21-g001.jpg

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Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth.

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Considerations for pharmacoepidemiological analyses in the SARS-CoV-2 pandemic.

Pharmacoepidemiol Drug Saf. 2020 Aug;29(8):825-831. doi: 10.1002/pds.5029. Epub 2020 May 21.

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

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Real-World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value.

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Real-World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value.

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