Buyse M
International Institute for Drug Development (ID2), Brussels, Belgium.
Stat Med. 1993 Mar;12(5-6):509-20. doi: 10.1002/sim.4780120517.
A survey was carried out to identify the current policies of European cooperative groups with respect to interim analyses, stopping rules and data monitoring of ongoing clinical trials. The policies differ widely, from informal interim analyses distributed among all participating investigators, to planned interim analyses carried out by an independent statistician and scrutinized by a data monitoring committee. Different situations clearly call for different policies: for instance, trials of new drugs in AIDS need to be monitored more closely than trials of non-toxic adjuvant therapies for cancer. Likewise, trials with an immediately measurable end-point (such as the large-scale trials in myocardial infarction) need more intensive monitoring than those in which the outcome assessment requires prolonged follow-up. In all cases, however, it seems useful to articulate explicit data monitoring procedures in the trial protocol. In general, an independent data monitoring committee is essential to advise on the desirability to continue accrual into the trial, or to stop it early.
开展了一项调查，以确定欧洲合作组织在进行中的临床试验的期中分析、停止规则和数据监测方面的现行政策。这些政策差异很大，从分发给所有参与研究者的非正式期中分析，到由独立统计学家进行并由数据监测委员会审查的计划期中分析。不同的情况显然需要不同的政策：例如，艾滋病新药试验比癌症无毒辅助治疗试验需要更密切的监测。同样，具有即时可测量终点的试验（如心肌梗死的大规模试验）比那些结果评估需要长期随访的试验需要更密集的监测。然而，在所有情况下，在试验方案中阐明明确的数据监测程序似乎都是有用的。一般来说，一个独立的数据监测委员会对于就是否继续纳入试验或提前停止试验提供建议至关重要。
