국내 임상시험약국의 인프라 및 운영 실태에 관한 설문 연구

• Published in: 병원약사회지, 42(3) pp. 223 - 234
• Main Authors: 김새미, 김민경, 이진아, 구해민, 임미경, 우택, 이연지, 장순옥, 유예진, 이주연, 장홍원, 아영미
• Format: Journal Article
• Language: Korean
• Published: 한국병원약사회 01.08.2025
• Subjects: 약학
• ISSN: 1226-640X; 2466-2143

Background: South Korea has emerged as a global leader in clinical research, ranking fourth worldwide in sponsor-initiated trials in 2023. With more than 700 trials approved annually over the past five years, the need for appropriate investigational product (IP) management infrastructure—space, equipment, and specialized personnel— has become increasingly important. However, limited data exist on operational environments of clinical trial pharmacies in Korea. Methods: A nationwide cross-sectional survey was conducted from June 17, 2024 to July 31, 2024. One clinical trial pharmacist from each of 68 designated institutions (32.4% of total sites) responded to a structured questionnaire. The survey assessed physical infrastructure, staffing levels, equipment availability, aseptic preparation environments, and experience with advanced therapy medicinal products (ATMPs). Descriptive statistics were used for analysis. Results: Participating institutions conducted an average of 153 clinical trials, with five sites managing more than 500 trials each. Most (77.9%) institutions had dedicated space for clinical trial pharmacy services. However, nearly half (47.1%) operated within <66.12 m². Only 23.5% had ultra-low temperature freezers. None had nitrogen tanks. Dedicated aseptic rooms were present in 30.9% of institutions. IP-dedicated biological safety cabinets (BSCs) were present in 36.7%. Among 16 institutions with ATMP trial experience, 15 responded. All 15 had handled cell therapies and seven had conducted gene therapy trials. Conclusion: There are substantial variations in infrastructure and staffing among clinical trial pharmacies in Korea. High trial volumes are associated with limited space and increased workload per pharmacist, potentially compromising IP management quality and patient safety. Investments in specialized facilities, equipment, and personnel are necessary to support the growing complexity and scale of clinical trials. This study provides essential baseline data to guide standardization and policy development for clinical trial pharmacy operations. KCI Citation Count: 0