Finney D J
Stat Med. 1982 Apr-Jun;1(2):153-61. doi: 10.1002/sim.4780010208.
The risk that a drug newly introduced into medical use will occasionally cause adverse reactions is neither negligible nor totally avoidable. Only well organized systems of monitoring can bring early detection and appropriate action. These in turn require either detailed supervision or spontaneous reporting. The paper is concerned with statistical inference from reports spontaneously submitted, and its logical limitations; it discusses strengths and weaknesses of the UK system, the detection process, and automated signalling.
新投入医疗使用的药物偶尔会引起不良反应，这种风险既不可忽视，也无法完全避免。只有组织完善的监测系统才能实现早期发现并采取适当行动。而这反过来又需要详细的监督或自发报告。本文关注的是从自发提交的报告中进行统计推断及其逻辑局限性；讨论了英国系统的优缺点、检测过程以及自动信号提示。
