An Overview of Quality Management of Therapeutic Vaccines in Clinical Trials in China

Abstract

Objective To provide suggestions and a reference for improving the quality management system of clinical trials of therapeutic vaccines and promoting the development of therapeutic vaccines in China. Methods Literature research, case study and comparative study were used to analyze the quality management system of clinical trials of therapeutic vaccines. Results and Conclusion From the perspective of the sponsor, investigators and the thirdparty technical service company, the problems such as the low efficiency of clinical trial sample preparation and the lax implementation of the protocol by hospital departments in the quality management of clinical trials of therapeutic vaccines in China were found. Then, the optimization plan for the quality management of clinical trials of therapeutic vaccines is proposed, including optimizing the preparation process of therapeutic vaccines and strengthening the training of hospital department personnel.

Keywords

therapeutic vaccine / clinical trial / quality management / good clinical practice (GCP)

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