新药不良反应的识别。III：警示流程与早期预警系统。
Identification of adverse reactions to new drugs. III: Alerting processes and early warning systems.
作者信息
Venning G R
出版信息
Br Med J (Clin Res Ed). 1983 Feb 5;286(6363):458-60. doi: 10.1136/bmj.286.6363.458.
Abstract
The process of discovery for 18 important adverse drug reactions was analysed in terms of study designs and other features which determined whether published reports of suspected adverse reactions were convincing or provided valid evidence of causality. First alerts were almost always anecdotal reports. For earlier alerting during clinical trials event recording is needed, associated with dose-response data and the use of patients as their own controls.
摘要
从研究设计和其他特征方面分析了18种重要药物不良反应的发现过程，这些特征决定了已发表的疑似不良反应报告是否具有说服力或是否提供了因果关系的有效证据。首次警报几乎总是轶事报告。为了在临床试验期间更早发出警报，需要进行事件记录，并结合剂量反应数据以及将患者自身作为对照。
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Identification of adverse reactions to new drugs. II (continued): How were 18 important adverse reactions discovered and with what delays?新药不良反应的识别。II（续）：18种重要不良反应是如何被发现的，以及延迟了多久？
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4
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5
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