임상시험 승인일과 실제 개시일 사이의 소요기간 분석

• Published in: Yaghag-hoi-ji Vol. 69; no. 3; pp. 256 - 262
• Main Author: 조새미(Saemi Cho), 이상원(Sang-Won Lee)
• Format: Journal Article
• Language: Korean
• Published: The Pharmaceutical Society Of Korea 30.06.2025; 대한약학회
• Subjects: 약학; Clinical trial initiation period; Oncology drugs; KOSPI listing; Effective factors
• ISSN: 0377-9556; 2383-9457

This study analyzed the time required from IND approval to the initiation of clinical trials for drugs developed by domestic pharmaceutical companies in South Korea between 2018 and 2022. Additionally, it examined the key factors influencing the initiation period. The results showed that the average time for trial initiation was 112.24 days, with oncology-related clinical trials requiring the longest period, averaging 174.16 days. Factors such as clinical trial phase, whether the drug is a biologic, oncology drug status, the presence of a collaborator, number of subjects, and whether the company is publicly listed on the KOSPI market were analyzed for their impact on initiation periods. The findings revealed that oncology clinical trials required significantly longer initiation periods compared to non-oncology trials (t=3.067, p<.01). Conversely, KOSPI-listed companies were found to significantly reduce initiation periods compared to non-listed companies (β=-.197, p<.01). These results suggest that the characteristics of the drug and structural factors of the sponsor company have a substantial impact on the initiation period of clinical trials conducted by domestic pharmaceutical companies. This study highlights the need for strategic approaches to improve the efficiency of clinical trial initiation processes. KCI Citation Count: 0