Current Status and Construction Requirements of Drug Clinical Trial Institutions in Sichuan Province in China
摘要
This paper aims to systematically analyze the distribution, capacity status, and development trends of drug clinical trial institutions in Sichuan Province, and explore future construction directions and core requirements. A descriptive quantitative research design was adopted, including descriptive statistical analysis of national and provincial filing data, trend analysis of institutional development, and supplementary policy document review. The situational analysis indicates that Sichuan’s drug clinical trial institutions exhibit a pattern of “high concentration in core areas and multi-point development in other regions”: 50.6% of institutions are concentrated in Chengdu, while 5 prefecture-level cities still lack qualified institutions. This study has three distinct contributions: First, it is the first systematic analysis of Sichuan’s drug clinical trial institutions based on post-2019 filing system data, revealing regional and professional disparities; Second, it proposes a “1 + N” regional collaborative construction framework tailored to western China’s characteristics; Finally, it provides actionable policy recommendations for institutional quality improvement under strict regulatory requirements. From the perspective of development potential, future construction priorities should shift from “quantitative expansion” to “qualitative leap,” comprehensively enhancing institutional capabilities through standardization, specialization, and digitalization. These improvements are expected to better undertake national major new drug development tasks, empower high-quality development of the biomedical industry, and may serve as a reference for gradually improving patient access to innovative treatments in the long term.