Application Values of Real-World Evidence in Post-Marketing Surveillances and Evaluation for Drug Safety

doi:10.19803/j.1672-8629.2021.07.06

Abstract

Abstract: Objective To understand the application values of real-world evidence (RWE) in post-marketing surveillance and evaluation for drug safety. Methods Literatures related to RWE in post-marketing surveillance for drug safety were searched in PubMed, Embase, Web of Science, Scopus, SinoMed, CNKI, VIP, Wanfang Data from the establishment to January 2, 2020. Results and conclusion After research team and expert consultation, application values of RWE in post-marketing surveillance and evaluation for drug safety was summarized into four aspects, including supplementing drug safety evidence, auxiliary drug post-marketing management, supporting clinical decision-making and health policies, as well as technical methods development and optimization. And for each aspect reference cases were provided.

Key words: real world evidence, post-marketing surveillance, drug safety

CLC Number:

R994.11

MENG Ruogu, ZHUO Lin, QIAO Rui, LIU Yuqiang, SUN Feng, ZHAN Siyan. Application Values of Real-World Evidence in Post-Marketing Surveillances and Evaluation for Drug Safety[J]. Chinese Journal of Pharmacovigilance, 2021, 18(7): 624-627.

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