【摘要】 随机对照盲法临床试验用于评价疫苗安全性与有效性是公认的金标准，但由于其设计上的严苛，使得疫苗上市后，在大规模应用场景下的疫苗真实保护效果与临床试验获得的保护效力往往存在偏差，疫苗真实世界研究在此基础上被提出。新冠病毒疫苗真实世界研究被大量报道，其结果被各国采用，及时优化疫苗免疫策略。本文概括了常见的疫苗真实世界研究设计，并着重介绍了近些年发展出来的解决真实世界研究中混杂偏倚的统计方法 ：倾向评分和工具变量。更多还原

【Abstract】 Randomized controlled double-blind clinical trials are widely recognized as the gold standard for evaluating the safety and efficacy of vaccines. However, due to their rigorous design, a deviation often exists between the protection efficacy obtained in large-scale vaccine applications in real-world scenarios and the efficacy observed in clinical trials. Real world studies of vaccines have been proposed to address this issue. The real world study on COVID-19 vaccines, in particular, has been widely reported, and its results have been adopted by various countries to optimize vaccine immunization strategies. This article summarizes common designs for real world vaccine studies and focuses on recent statistical methods developed to address confounding bias in real world studies: propensity score and instrumental variable.更多还原