疫苗临床试验中创新性设计及统计学考量  

Innovative design and statistical considerations in vaccine clinical trials

作　　者：孙凤宇 刘文 丁思加 言方荣 王骏 彭志行[1,4,5] Sun Fengyu;Liu Wen;Ding Sijia;Yan Fangrong;Wang Jun;Peng Zhihang(Department of Biostatistics,School of Public Health,Nanjing Medical University,Nanjing 211166,China;Center for Drug Evaluation of the National Medical Products Administration,Beijing 100076,China;Department of Biostatistics,School of Science,China Pharmaceutical University,Nanjing 211198,China;Information Center of Chinese Center for Disease Control and Prevention,Beijing 102206,China;National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases,Chinese Center for Disease Control and Prevention,Beijing 102206,China)

机构地区：[1]南京医科大学公共卫生学院生物统计系,南京211166 [2]国家药品监督管理局药品审评中心,北京100076 [3]中国药科大学理学院生物统计系,南京211198 [4]中国疾病预防控制中心信息中心,北京102206 [5]中国疾病预防控制中心传染病溯源预警与智能决策全国重点实验室,北京102206

出　　处：《中华预防医学杂志》2025年第2期254-259,共6页Chinese Journal of Preventive Medicine

基　　金：国家重点研发计划项目(2024YFC2311500);国家自然科学基金(82320108018,12220101001)。

摘　　要：近几十年里,全球经历了多次重大病毒暴发,包括西非的埃博拉疫情、南美的寨卡病毒流行以及近期的全球COVID-19大流行。在这些疫情应对过程中,有效的疫苗为保护人民健康作出了重大贡献,但面对新发突发传染病防控不断出现的新问题,全球传统疫苗研发模式正面临前所未有的机遇与挑战,暴露了传统疫苗开发的时间长、成本高等局限性。本文探讨了现代疫苗临床试验中的创新设计,深入探讨针对疫苗特有的随机化方法,同时梳理了疫苗试验设计中的关键统计学考量,以期为疫苗开发提供科学支持,推动疫苗研发领域的持续创新与实践优化。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.

关 键 词：疫苗研发 创新性设计 群随机 统计学考量 

分 类 号：R392[医药卫生—免疫学]