Implementation status and quality improvement strategies of the record-filing system for drug clinical trial institutions in Sichuan Province.

Objective: This study systematically analyzes the implementation status and existing problems of the record-filing system for drug clinical trial institutions, proposes quality improvement strategies based on empirical data from Sichuan Province, and provides references for the optimization of the national record-filing system. Methods: Based on the National Drug Clinical Trial Institution Record-Filing Management Information Platform and publicly available data, descriptive statistics, trend analysis, and concentration analysis (Herfindahl-Hirschman Index, HHI) are adopted. Data cleaning was performed to exclude duplicate records and entries with missing key information (e.g., institution location, specialty registration). Key metrics were clearly defined: ① Institution coverage rate = (Number of registered institutions in the region/Total number of tertiary hospitals in the region) × 100%; ② Regional concentration degree was measured by HHI (calculated as the square of the proportion of institutions in each prefecture-level city to the provincial total); ③ Comparative indices included inter-provincial quantity ranking, intra-provincial regional distribution ratio, and specialty composition percentage. The study sorts out the number, regional distribution, specialty layout, and project undertaking characteristics of clinical trial institutions nationwide and in Sichuan Province, with a focus on analyzing the development differences between institutions in Chengdu and non-central cities. Results: As of September 9, 2025, China had 1,803 registered Good Clinical Practice (GCP) institutions. Sichuan Province ranks the 7th nationwide with 88 registered institutions; however, the distribution within the province is highly uneven (HHI = 0.25, indicating moderate concentration). Chengdu alone accounts for 50.00% of the total (44 institutions), while the coverage rate of institutions in regions such as Western Sichuan and Northeastern Sichuan is less than 30%. Internal medicine dominated the professional distribution (57 institutions, 64.77%), while advanced platforms such as Phase I clinical research units (22 institutions) remained relatively scarce. The number of registered PIs in the province reached 1,424, but only 32.7% were from non-Chengdu institutions. Chengdu Fifth People's Hospital undertook 203 projects following its record-filing, including 26 bioequivalence (BE) trials. Conclusion: The record-filing system has substantially expanded clinical trial resources in Sichuan Province. However, persistent challenges include regional disparities, suboptimal specialization structures, and inadequate quality systems. Newly established institutions should proactively address these common issues through high-standard development, thereby contributing to a more balanced, efficient, and high-quality clinical trial ecosystem in the province.