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KMID : 1138720190450030025
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Korean Public Health Research
2019 Volume.45 No. 3 p.25 ~ p.36
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Exploring the perception on real world data utilization in drug safety management using focus group interviews in South Korea : A qualitative study
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Park Han-Heui
Jung Gyu-Won
Shin Ju-Young
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Abstract
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Objectives : Since the passage of the FDA’s 21st Century Cures Act, there has been a worldwide interest in real world data (RWD). We aimed to diagnose the present situation of RWD in Korea and investigate the perception on RWD utilization in the field of drug safety management.
Methods : We conducted qualitative study using focus group interview with experts engaged in post-marketing and drug approval. Major themes were extracted by authors, which were used to gather results and draw conclusion.
Results : Interviewees established positive perception of RWD. Judging from the results of interview, RWD is valuable as a way to supplement existing post marketing surveillance (PMS) system. On the other hand, there are considerations when using RWD such as data source accessibility, workforce training, and data validation method.
Conclusions : This study suggests future development direction for establishing the approval system using RWD in Korea.
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KEYWORD
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Real World Data (RWD), Real World Evidence (RWE), Drug safety management, Post Marketing Surveillance (PMS), Focus Group Interview
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