Enlightenment and Reference of Vaccine Clinical Trial Design Based on
Immunological Surrogate Endpoints in the United States

亚洲社会药学 ›› 2021, Vol. 16 ›› Issue (1): 68-75.

Enlightenment and Reference of Vaccine Clinical Trial Design Based on Immunological Surrogate Endpoints in the United States

Gu Jinmeng, Yang Yue, Xing Hua*

School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China

出版日期:2021-03-20 发布日期:2021-03-19

Enlightenment and Reference of Vaccine Clinical Trial Design Based on Immunological Surrogate Endpoints in the United States

Gu Jinmeng, Yang Yue, Xing Hua*

School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China

Online:2021-03-20 Published:2021-03-19
Contact: Xing Hua, associate professor. Major research area: pharmaceutical policy and management, new drug R&D and project management, etc. Tel: 024-23986543, E-mail: gsglxyxh@126. com. E-mail:gsglxyxh@126. com

摘要/Abstract

摘要： Objectives To explore the optimization method of vaccine clinical trial design based on immunological surrogate endpoint to improve the quality and efficiency of vaccine clinical research and development. Methods As to the problems in the vaccine clinical research in China, the relevant guidelines and literatures of FDA and WHO were used to analyze and summarize the methods of optimizing the design of vaccine clinical trials. Results and Conclusion The adaptive design guidelines are established to guide clinical trial design, encourage the development and application of immunological surrogate endpoints, establish qualification process for drug development tools and information disclosure procedures to improve vaccine development efficiency.

关键词: vaccine, immunological surrogate endpoint, adaptive design

Abstract: Objectives To explore the optimization method of vaccine clinical trial design based on immunological surrogate endpoint to improve the quality and efficiency of vaccine clinical research and development. Methods As to the problems in the vaccine clinical research in China, the relevant guidelines and literatures of FDA and WHO were used to analyze and summarize the methods of optimizing the design of vaccine clinical trials. Results and Conclusion The adaptive design guidelines are established to guide clinical trial design, encourage the development and application of immunological surrogate endpoints, establish qualification process for drug development tools and information disclosure procedures to improve vaccine development efficiency.

Key words: vaccine, immunological surrogate endpoint, adaptive design

Gu Jinmeng, Yang Yue, Xing Hua. Enlightenment and Reference of Vaccine Clinical Trial Design Based on Immunological Surrogate Endpoints in the United States[J]. 亚洲社会药学, 2021, 16(1): 68-75.

Gu Jinmeng, Yang Yue, Xing Hua. Enlightenment and Reference of Vaccine Clinical Trial Design Based on Immunological Surrogate Endpoints in the United States[J]. Asian Journal of Social Pharmacy, 2021, 16(1): 68-75.

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Enlightenment and Reference of Vaccine Clinical Trial Design Based on Immunological Surrogate Endpoints in the United States

Enlightenment and Reference of Vaccine Clinical Trial Design Based on Immunological Surrogate Endpoints in the United States

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