한국 제약업계의 실사용데이터 활용 현황 및 발전 방향에 대한 설문조사 연구

• 영문명: The Current Status and Perspective of Real-World Data Use of Pharmaceutical Industries in Korea: A Survey Study
• 발행기관: 한국사회약학회 (구.한국보건사회약료경영학회)
• 저자명: 조해린 임은선 박수빈 조혜인 고하나 조민정 최남경
• 간행물 정보: 『한국사회약학회지』제11권 제1호, 9~16쪽, 전체 8쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2023.05.31

영문 초록

Backgrounds: Real-world data (RWD) are drawing ever-increasing attention in the pharmaceutical industry. We survey to understand the current status of RWD utilization and gather opinions on improving its usage. Methods: We surveyed RWD utilization related to pharmaceutical companies' conducting and planning RWD studies. A survey was distributed to 181 members of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association and 47 members of the Korean Research-based Pharma Industry Association on November 10, 2021. The questionnaire consisted of closedended and open-ended questions and was divided into three main parts: 1) experience of RWD studies, 2) plan of RWD studies, and 3) future of RWD development. Results: A total of 16 replies were received. Five of the respondents (31.2%) reported having experience conducting RWD studies, and eleven of the respondents (68.8%) reported having a plan for RWD studies. Most companies (81.3%) responded that no experts or departments were in charge of using RWD. Among them, 93.7% indicated that needed an education program to foster experts conducting RWD studies. Opinions on RWD utilization included resolving legal issues, expanding RWD acceptance by regulatory agencies, revising related regulations, and securing professional personnel. Conclusion: Although the low response rate, this study is meaningful in that only those currently interested in using RWD who are aware of the challenges responded. The survey indicates that most pharmaceutical companies have little experience conducting RWD studies but plan to conduct RWD studies. Therefore, we suggest establishing relevant guidelines for using RWD and nurturing infrastructures that can professionally handle RWD.

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real-world data real-world evidence pharmaceutical policy survey the pharmaceutical industry