Innovative trial designs and analyses for vaccine clinical development.
Innovative trial designs and analyses for vaccine clinical development.
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DOI：
10.1016/j.cct.2020.106225
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发表时间：
2021-01
影响因子：
2.2
通讯作者：
Hoffman E
中科院分区：
文献类型：
--
作者：
Liu M;Li Q;Lin J;Lin Y;Hoffman E
在过去的几十年里，世界经历了几次重大的病毒爆发，例如西非埃博拉病毒爆发，南美洲的寨卡病毒和最近的全球冠状病毒（COVID-19）大流行。许多疫苗已经被开发出来，成功地预防了各种传染病。然而，到目前为止，一些感染尚无法预防，如COVID-19，这导致对有效疫苗的迫切需求。这些新出现的传染病往往对全球卫生界以及传统的疫苗开发模式构成前所未有的挑战。由于传统的疫苗开发过程漫长而昂贵，因此对创新的疫苗试验设计和分析有着广泛的需求，其目的是设计更有效的疫苗试验。这些更有效的试验具有缩短开发时间轴、减少资源消耗或改善对感兴趣终点的估计的特点，以更快、更低成本的方式为目标人群提供有效药物。本文将回顾一些具有适应性设计特征的疫苗试验、适应历史数据借用的贝叶斯设计、COVID-19疫苗开发过程中出现的主方案策略、真实世界数据（RWD）嵌入式试验以及保护框架与相关研究工作的关联。我们还将讨论一些统计方法，提高疫苗的有效性，安全性和免疫原性分析。创新的临床试验设计和分析，加上先进的研究技术和对人类免疫系统的更深入了解，正在为未来有效开发新疫苗铺平道路。
In the past decades, the world has experienced several major virus outbreaks, e.g. West African Ebola outbreak, Zika virus in South America and most recently global coronavirus (COVID-19) pandemic. Many vaccines have been developed to prevent a variety of infectious diseases successfully. However, several infections have not been preventable so far, like COVID-19, which induces an immediate urgent need for effective vaccines. These emerging infectious diseases often pose unprecedent challenges for the global heath community as well as the conventional vaccine development paradigm. With a long and costly traditional vaccine development process, there are extensive needs in innovative vaccine trial designs and analyses, which aim to design more efficient vaccines trials. Featured with reduced development timeline, less resource consuming or improved estimate for the endpoints of interests, these more efficient trials bring effective medicine to target population in a faster and less costly way. In this paper, we will review a few vaccine trials equipped with adaptive design features, Bayesian designs that accommodate historical data borrowing, the master protocol strategy emerging during COVID-19 vaccine development, Real-World-Data (RWD) embedded trials and the correlate of protection framework and relevant research works. We will also discuss some statistical methodologies that improve the vaccine efficacy, safety and immunogenicity analyses. Innovative clinical trial designs and analyses, together with advanced research technologies and deeper understanding of the human immune system, are paving the way for the efficient development of new vaccines in the future.
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