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

摘要/Abstract

摘要： 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 third-party 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.

关键词: therapeutic vaccine, clinical trial, quality management, good clinical practice (GCP)

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 third-party 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.

Key words: therapeutic vaccine, clinical trial, quality management, good clinical practice (GCP)

Lin Hansen, Tian Lijuan. An Overview of Quality Management of Therapeutic Vaccines in Clinical Trials in China[J]. 亚洲社会药学, 2024, 19(1): 50-57.

Lin Hansen, Tian Lijuan. An Overview of Quality Management of Therapeutic Vaccines in Clinical Trials in China[J]. Asian Journal of Social Pharmacy, 2024, 19(1): 50-57.

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