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미국, 유럽, 일본의 실사용데이터 연구사업 추진현황과 시사점
박한희(Han-Heui Park),정규원(Gyu-Won Jung),성희진(Higin Sung),신주영(Ju-Young Shin) 대한약학회 2020 약학회지 Vol.64 No.1
With the growing interest in big data, regulatory agencies in United States, Europe, and Japan are showing active movements to use real world data (RWD) and real world evidence (RWE). Following the global movements, it is necessary to establish the foundation for utilizing RWD in drug safety management in Korea. The purpose of this study is to examine and analyze the current status of research projects related to RWD in US, Europe, and Japan. We investigated the current state of global research projects on the use of RWD and RWE by utilizing many of the informative resources as follow. We collected information posted on websites operated by each country’s regulatory authority. 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. We classified research projects into 4 areas; data integrity (accuracy and consistency of data), post-market drug safety monitoring, indication expansion, and consulting and education fields. In this way, we could consider each country’s different market environment and institutional bases. Therefore, this study suggests future directions to prepare research projects for the introduction of Korea’s RWD.
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