Objective To analyze the policy texts of vaccine clinical trials in China and identify the characteristics, issues, and directions for improvement in the quality management.
Methods Seventeen policy documents issued at the central level between January 2001 and December 2024 were obtained through a systematic search of the official websites of the State Council and relevant ministries. A three-dimensional analytical framework consisting of tools, elements, and strength was developed, integrating content analysis and the Latent Dirichlet Allocation (LDA) topic model to uncover the latent thematic structures within these policy texts.
Results The findings indicated a significant imbalance in the deployment of policy tools for vaccine clinical trials. The utilization of inducements (1.23%, 2 codes), symbolic and hortatory tools (3.09%, 5 codes), capacity-building tools (7.41%, 12 codes), and system-changing tools (9.89%, 16 codes) remained insufficient. Furthermore, the distribution of policy elements was uneven, with limited emphases on clinical trial design (4.94%, 8 codes), trial participants (3.09%, 5 codes), and trial contents (6.17%, 10 codes). Policy intensity also exhibited substantial disparities, lacking synergy and alignment among policy elements, tools, and intensity. The overall thematic coordination of the policies was effective, jointly contributing to the improvement of the vaccine trial regulatory system.
Conclusions In the future, efforts should be made to enhance the balanced utilization of policy tools, optimize policy structures, prioritize vaccine clinical trial design, and adopt diverse and flexible design methodologies, thus improving the scientific rigor and practical applicability of vaccine trials.
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