Pignon J P, Tarayre M, Auquier A, Arriagada R, Le Chevalier T, Ruffié P, Rivière A, Monnet I, Chomy P, Tuchais C
Department of Biostatistics and Epidemiology, Institut Gustave-Roussy, Villejuif, France.
Stat Med. 1994;13(13-14):1415-21. doi: 10.1002/sim.4780131317.
The triangular test has been used to monitor survival data from a randomized trial in patients with small cell lung cancer. The results of consecutive interim analyses and the problems met by the data monitoring committee and the co-ordinators are described. The methods as well as the consequences of the early stopping on the analysis and the results of this trial are discussed. From this experience, we believe that statistical stopping rules--only one of the factors to be taken into account when deciding to stop a trial--should be used with caution. Independent data monitoring committees may be useful in helping to review the ongoing results and advise the participants in the trial.
三角检验已被用于监测小细胞肺癌患者随机试验的生存数据。文中描述了连续中期分析的结果以及数据监测委员会和协调员遇到的问题。讨论了早期终止试验的方法及其对分析和试验结果的影响。从这次经验中，我们认为统计停止规则——在决定终止试验时需考虑的因素之一——应谨慎使用。独立的数据监测委员会可能有助于审查试验的进展结果并为试验参与者提供建议。
