Innovative design and statistical considerations in vaccine clinical trials
10.3760/cma.j.cn112150-20240228-00163
- VernacularTitle:疫苗临床试验中创新性设计及统计学考量
- Author:
Fengyu SUN
1
;
Wen LIU
;
Sijia DING
;
Fangrong YAN
;
Jun WANG
;
Zhihang PENG
Author Information
1. 南京医科大学公共卫生学院生物统计系，南京 211166
- Publication Type:Journal Article
- Keywords:
Vaccine development;
Innovative design;
Cluster randomization;
Statistical considerations
- From:
Chinese Journal of Preventive Medicine
2025;59(2):254-259
- CountryChina
- Language:Chinese
-
Abstract:
In recent decades, the global community has encountered several significant viral outbreaks, including the Ebola epidemic in West Africa, the Zika virus epidemic in South America, and the recent worldwide COVID-19 pandemic. In these instances, the deployment of effective vaccines has been instrumental in protecting public health. Nevertheless, as new challenges emerge in the prevention and management of infectious diseases, the traditional model of global vaccine development confronts both unprecedented opportunities and challenges. These circumstances underscore the limitations inherent in conventional vaccine development, particularly the protracted timelines and substantial costs involved. This article examines innovative approaches in contemporary vaccine clinical trials, investigates randomization techniques specific to vaccine studies, and delineates essential statistical considerations pertinent to vaccine trial design. The objective is to provide scientific support for vaccine development and to foster ongoing innovation and optimization within the realm of vaccine research and development.
