Application Scope of Real-World Data in Post-Marketing Drug Safety Monitoring and Evaluation for Drug Safety

doi:10.19803/j.1672-8629.2021.07.05

Abstract

Abstract: Objective To analyze and summarize the application status of real-world data (RWD) in post-marketing drug safety monitoring and evaluation. Methods The literature related to RWD and post-marketing drug safety were searched and statistical analyzed in PubMed, Embase, SinoMed, CNKI and other databases from the establishment to January 2, 2020. Results The scope of application of RWD in post-marketing drug safety monitoring and evaluation research is mainly reflected in 3 aspects, including research design, drug categories and clinical problems. Conclusion RWD has a wide range of applications in post-marketing drug safety monitoring and evaluation. The full and reasonable use of RWD to carry out real-world study (RWS) can open up a new way for the active monitoring and evaluation of drug safety after marketing.

Key words: real-world data, scope of application, safety evaluation, post-marketing drug monitoring

CLC Number:

R994.11

QIAO Rui, LIU Yuqiang, ZHUO Lin, MENG Ruogu, SUN Feng, ZHAN Siyan. Application Scope of Real-World Data in Post-Marketing Drug Safety Monitoring and Evaluation for Drug Safety[J]. Chinese Journal of Pharmacovigilance, 2021, 18(7): 620-623.

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