Clinical trials for accelerating pandemic vaccines
概述了适应性试验、人类挑战试验和分剂量接种等加速疫苗研发的临床试验方法，分析了其风险收益，并总结了新冠疫情中的经验教训，为下次大流行提供指导。
Abstract We provide a short overview of clinical trials of vaccines, with particular focus on (i) adaptive and platform trials, (ii) human challenge trials, and (iii) vaccine use optimization, especially fractional dosing. We describe their relationship with regulatory approval and review main developments during Covid-19. We review the literature on risk–benefit analyses of alternative testing approaches but find few results, suggesting need for further quantitative research. We conclude by discussing some lessons for the next pandemic, such as the need for pre-pandemic R&D and clear guidelines; improving capability to use new trial approaches; arguments for diversifying research methods; research incentives and disincentives; and the need to use risk–benefit in approving new vaccines and targeting.