Lipsitch Marc, Eyal Nir
Center for Communicable Disease Dynamics, Department of Epidemiology, and Department of Immunology and Infectious Diseases, Harvard T. H. Chan School of Public Health, Boston, MA, USA.
Department of Global Health and Population, Harvard T. H. Chan School of Public Health, Boston, MA, USA.
Science. 2017 Jul 14;357(6347):153-156. doi: 10.1126/science.aam8334.
Unprecedented global effort is under way to facilitate the testing of countermeasures in infectious disease emergencies. Better understanding of the various options for trial design is needed in advance of outbreaks, as is preliminary global agreement on the most suitable designs for the various scenarios. What would enhance the speed, validity, and ethics of clinical studies of such countermeasures? Focusing on studies of vaccine efficacy and effectiveness in emergencies, we highlight three needs: for formal randomized trials-even in most emergencies; for individually randomized trials-even in many emergencies; and for six areas of innovation in trial methodology. These needs should inform current updates of protocols and roadmaps.
全球正在进行前所未有的努力，以促进在传染病紧急情况下对对策进行测试。在疫情爆发之前，需要更好地了解试验设计的各种选择，同时也需要就针对各种情况的最合适设计达成初步的全球共识。如何提高此类对策临床研究的速度、有效性和伦理水平？聚焦于紧急情况下疫苗效力和效果的研究，我们强调三点需求：进行正式的随机试验——即使在大多数紧急情况下；进行个体随机试验——即使在许多紧急情况下；以及在试验方法上进行六个方面的创新。这些需求应作为当前方案和路线图更新的依据。
