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한국 제약업계의 실사용데이터 활용 현황 및 발전 방향에 대한 설문조사 연구
조해린(Haerin Cho), 임은선(Eunsun Lim), 박수빈(Suvin Park), 조혜인(Haein Cho), 고하나(Hana Go), 조민정(Minjung Cho), 최남경(Nam-Kyong Choi) 한국보건사회약료경영학회 2023 한국보건사회약료경영학회지 Vol.11 No.1
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.