Innovative clinical trial designs for vaccine development
10.3969/j.issn.1672-8467.2025.02.021
- VernacularTitle:针对疫苗研发的临床试验创新设计
- Author:
Dan-ni ZHAO
1
;
Zhuo-ying HUANG
;
Jie TIAN
;
Tao ZHANG
;
Wei-bing WANG
Author Information
1. 上海市重大传染病和生物安全研究院 上海 200032;复旦大学公共卫生学院流行病学教研室-公共卫生安全教育部重点实验室 上海 200032
- Publication Type:Journal Article
- Keywords:
vaccine clinical trials;
adaptive design;
Bayesian design;
master protocol design;
real-world data(RWD)
- From:
Fudan University Journal of Medical Sciences
2025;52(2):311-316
- CountryChina
- Language:Chinese
-
Abstract:
During sudden outbreaks of major infectious diseases,traditional vaccine clinical trials often fail to deliver timely and meaningful outcomes.To address this,innovative trial designs are essential to accelerate or restructure the traditional three-phase clinical trial process while maintaining adherence to scientific principles of drug candidate safety and efficacy.This paper presents various innovative vaccine clinical trial designs and concepts,along with critical considerations for their application,to serve as a methodological reference for related research.Adaptive designs provide flexibility by dynamically adjusting trial parameters—such as dose selection,population stratification,and sample size reestimation—based on interim analysis results.Bayesian designs incorporate historical data and prior information,reducing sample size requirements.Master protocol designs enable the evaluation of multiple treatments or target populations within a unified framework,significantly improving efficiency.Additionally,real-world data(RWD),including electronic health records vaccination records and insurance claims,supports the creation of virtual control groups,addressing ethical concerns while enhancing trial feasibility.A hybrid design combining randomized controlled trials(RCTs)with RWD is also proposed to leverage the strengths of both methodologies.These innovative designs optimize the research process,accelerating vaccine development and regulatory approval.By integrating these approaches,robust evidence-based insights can be generated,advancing precision medicine goals and strengthening public health responses to emerging infectious diseases.
