Naranjo C A
Drug Inf J. 1986;20(4):387-93. doi: 10.1177/009286158602000403.
The study of a new drug includes the assessment of its pharmacologic effects, benefits (efficacy), and risks (safety). Most recent drug discontinuations in the United States and the United Kingdom have been associated with problems of safety. The assessment of clinical drug safety is difficult. Those assessing drug safety are confronted with the need to make causality assessment judgments of drug-related events. Several procedures for assessing causality of adverse reactions have been proposed; however, none of them is completely satisfactory. Global introspection (the unaided judgment based on knowledge and experience) and the currently available standardized decision aids (questionnaires or algorithms) have serious limitations that hamper their use. There is a need for better procedures.
对新药的研究包括对其药理作用、益处（疗效）和风险（安全性）的评估。美国和英国近期停用的大多数药物都与安全性问题有关。临床药物安全性评估很困难。评估药物安全性的人员面临着对药物相关事件进行因果关系评估判断的需求。已经提出了几种评估不良反应因果关系的程序；然而，没有一种是完全令人满意的。整体自省（基于知识和经验的无辅助判断）和目前可用的标准化决策辅助工具（问卷或算法）存在严重局限性，阻碍了它们的使用。需要更好的程序。
