临床试验中记录事件的理由。
The case for recording events in clinical trials.
作者信息
Skegg D C, Doll R
出版信息
Br Med J. 1977 Dec 10;2(6101):1523-4. doi: 10.1136/bmj.2.6101.1523.
Abstract
The value of clinical trials in detecting unwanted effects of new medicines would be enhanced if doctors recorded all adverse events experienced by patients and not just those regarded as adverse reactions to drugs. All events should be reported to the centre co-ordinating the trial and analysed in treated patients and controls. This method might have revealed the ocular toxicity of practolol before the drug was marketed in 1970.
摘要
如果医生记录患者经历的所有不良事件，而不仅仅是那些被视为药物不良反应的事件，那么临床试验在检测新药不良影响方面的价值将会提高。所有事件都应报告给协调试验的中心，并在治疗组患者和对照组中进行分析。这种方法可能在1970年心得宁上市之前就揭示其眼部毒性。
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