Donaldson A N, Whitehead J, Stephens R, Machin D
Department of Applied Statistics, University of Reading, UK.
Br J Cancer. 1993 Dec;68(6):1171-8. doi: 10.1038/bjc.1993.499.
The motivation for proposing sequential methods for cancer clinical trials is presented, and the methodology examined by re-analysing two completed phase III cancer trials of the Lung Cancer Working Party of the British Medical Research Council. The reanalysis proceeds as if the trials had been designed with a planned series of interim analyses governing stopping. Specifically, the triangular and double-triangular tests were applied. The sequential reanalysis gave a substantial reduction in the number of patient required, and deaths observed, for conclusions to be reached in comparison with the completed studies. In each case, the sequential analysis was stratified for baseline prognostic factors which were seen to be important at the first interim analysis.
本文介绍了提出癌症临床试验序贯方法的动机，并通过重新分析英国医学研究理事会肺癌工作组的两项已完成的III期癌症试验来检验该方法。重新分析的过程就好像这些试验在设计时就有一系列计划好的中期分析来控制试验停止。具体来说，应用了三角检验和双三角检验。与完成的研究相比，序贯重新分析在得出结论时所需的患者数量和观察到的死亡人数都大幅减少。在每种情况下，序贯分析都根据基线预后因素进行了分层，这些因素在首次中期分析时被认为是重要的。
