미국, 유럽, 일본의 실사용데이터 연구사업 추진현황과 시사점

• 영문명: Research Status and Implications of Real world data in the United States, Europe and Japan
• 발행기관: 대한약학회
• 저자명: 박한희(Han-Heui Park) 정규원(Gyu-Won Jung) 성희진(Higin Sung) 신주영(Ju-Young Shin)
• 간행물 정보: 『약학회지』제64권 제1호(2020년), 54~64쪽, 전체 11쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2020.02.29

영문 초록

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.

목차

서 론(Introduction)

연구방법(Research Methods)

결 과(Results)

고 찰(Discussion)

결 론(Conclusion)

감사의 말씀(Acknowledgment)

Conflict of Interest

References

키워드

Real world data (RWD) real world evidence (RWE) research project drug safety management