Director of Research, Center for Health Research Southeast, 3495 Piedmont Rd NE, Suite 110, Atlanta, GA 303035, USA.
Pharmaceutics. 2013 Mar 12;5(1):168-78. doi: 10.3390/pharmaceutics5010168.
Since the late 1990s, there have been tremendous strides made in improving the capacity for carrying out routine active surveillance of new vaccines in the United States. These strides have led to new surveillance systems that are now in place. Some of the critical elements that are part of successful vaccine or drug safety surveillance systems include their use of (i) longitudinal data from a discrete enumerated population base, (ii) frequent, routine transfers of small amounts of data that are easy to collect and collate, (iii) avoidance of mission creep, (iv) statistical capabilities, (v) creation of an "industrialized process" approach and (vi) political safe harbor.
自 20 世纪 90 年代末以来，美国在提高常规性主动监测新型疫苗能力方面取得了巨大进展。这些进展带来了新的监测系统。成功的疫苗或药物安全监测系统的一些关键要素包括：（i）来自离散枚举人群基础的纵向数据；（ii）频繁、常规地传输易于收集和整理的少量数据；（iii）避免任务扩展；（iv）统计能力；（v）创建“工业化流程”方法；以及（vi）政治安全港。
