Application of master protocol design in the clinical evaluation of infectious disease vaccines
10.3760/cma.j.cn112338-20240812-00492
- VernacularTitle:主方案设计在传染病疫苗临床评价中的应用
- Author:
Wenqing LIU
1
;
Yuqing LI
;
Lairun JIN
;
Pengfei JIN
;
Fengcai ZHU
;
Jingxin LI
Author Information
1. 南京医科大学公共卫生学院，南京 211166
- Publication Type:Journal Article
- Keywords:
Master protocol design;
Clinical evaluation of vaccines;
Infectious diseases
- From:
Chinese Journal of Epidemiology
2025;46(4):724-729
- CountryChina
- Language:Chinese
-
Abstract:
The master protocol design encompasses a comprehensive clinical trial protocol containing multiple sub-protocols, which can be used to evaluate the clinical intervention effects of various drugs or vaccines on various diseases. Particularly, this design strategy represents an efficient and innovative approach to trial design in the context of precision medicine. The master protocol design can be used for emerging infectious diseases and urgent vaccine development in complex situations. This review aims to outline the types and concepts of master protocol design, analyze the key points and details, and discuss its application scenarios in vaccine clinical evaluations. Additionally, it will explore potential challenges that may arise during implementation to provide references for optimizing emergency clinical trial designs of infectious disease vaccines in China.
