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KMID : 0370220200640010054
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Yakhak Hoeji
2020 Volume.64 No. 1 p.54 ~ p.64
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Research Status and Implications of Real world data in the United States, Europe and Japan
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Park Han-Heui
Jung Gyu-Won
Sung Hi-Gin
Shin Ju-Young
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Abstract
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With the growing interest in big data, regulatory agencies in United States, Europe, and Japan are showingactive movements to use real world data (RWD) and real world evidence (RWE). Following the global movements, it isnecessary to establish the foundation for utilizing RWD in drug safety management in Korea. The purpose of this studyis to examine and analyze the current status of research projects related to RWD in US, Europe, and Japan. Weinvestigated the current state of global research projects on the use of RWD and RWE by utilizing many of theinformative resources as follow. We collected information posted on websites operated by each country’s regulatoryauthority. Also we referred to publications and guidance around the enhanced use of RWE for health-care decision-makers. In addition, web seminars introducing ongoing research projects allowed us to gain substantial amount of resources. Weclassified research projects into 4 areas; data integrity (accuracy and consistency of data), post-market drug safetymonitoring, indication expansion, and consulting and education fields. In this way, we could consider each country’sdifferent market environment and institutional bases. Therefore, this study suggests future directions to prepare researchprojects for the introduction of Korea’s RWD.
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KEYWORD
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Real world data (RWD), real world evidence (RWE), research project, drug safety management
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