| 高书瑜,李靖欣,金鹏飞,朱凤才.整群随机设计在疫苗临床试验中的应用[J].Chinese journal of Epidemiology,2021,42(12):2221-2225 |
| 整群随机设计在疫苗临床试验中的应用 |
| Application of cluster randomization design in vaccine clinical trials |
| Received:June 22, 2021 |
| DOI：10.3760/cma.j.cn112338-20210622-00491 |
| KeyWord: 疫苗 临床试验 群体保护 |
| English Key Word: Vaccine Clinical trial Herd protection |
| FundProject: |
| Author Name | Affiliation | E-mail | | Gao Shuyu | School of Public Health, Southeast University, Nanjing 210009, China | | | Li Jingxin | Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China | | | Jin Pengfei | Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China | | | Zhu Fengcai | School of Public Health, Southeast University, Nanjing 210009, China
Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China
National Health Commission Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China | jszfc@vip.sina.com |
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| Abstract: |
| 当疫苗在人群中的覆盖率达到一定比例时，群体保护效果将保护未接种疫苗者。但传统疫苗临床评价采用的个体随机设计无法评估疫苗的群体保护效果。相较于个体随机设计，整群随机设计可以更全面地评估疫苗的总体保护效应。近年来，在疫苗临床的Ⅲ、Ⅳ期临床试验中，整群随机设计变得更加常见。但目前国内对整群随机设计在疫苗临床试验中的应用了解较少。因此，本文对整群随机设计在疫苗临床试验中的应用进行综述，为今后我国开展相关方面的研究提供参考。 |
| English Abstract: |
| When the coverage of the vaccinated people reaches a certain percentage of the population, the herd protection will protect the unvaccinated persons. However, the traditional clinical evaluation of vaccines performing individual randomized design fails to evaluate the herd protection of vaccines. Compared with the individual randomized design, the cluster-randomized design can determine the overall protection by the vaccine more comprehensively. It has become increasingly common to perform a cluster-randomized design in clinical trials of vaccines in Phase Ⅲ and Ⅳ clinical trials. However, little is known about the application of cluster randomized design in vaccine clinical trials in China. We, at this moment, do a review of the application of random cluster design in vaccine clinical trials and provide references for future research in China. |
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