Using provisional diagnoses in monitoring a clinical trial.
Using provisional diagnoses in monitoring a clinical trial.
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使用临时诊断来监测临床试验。
DOI：
10.1002/sim.4780100903
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发表时间：
1991
影响因子：
2
通讯作者：
Karon,JM
中科院分区：
文献类型：
--
作者：
Karon,JM
在临床试验中，事件发生与将该事件记录为试验数据库中的终点之间存在延迟。如果仔细审查事件以确定是否满足终点的诊断标准，则延迟尤其可能。因此，在试验期间用于评价疗效的统计量值可能不同于基于所有已发生事件的真实终点状态的统计量值。模拟导致延迟的过程可以通过提供监测统计中不确定性的定量估计来评估中期疗效数据。这些想法是用脂质研究诊所冠状动脉一级预防试验的数据来说明的。
In clinical trials there is delay between the occurrence of an event and the recording of that event as an end point in the trial data base. Delays are especially likely if events are reviewed carefully to determine whether diagnostic criteria for end points are satisfied. As a result, the value of a a statistic used to evaluate efficacy during a trial may differ from the value of that statistic based on the true end point status of all events which have already occurred. Simulating the process causing delays can be useful in evaluating interim efficacy data by providing a quantitative estimate of the uncertainty in a monitoring statistic. These ideas are illustrated using data from the Lipid Research Clinics Coronary Primary Prevention Trial.