Falissard B, Lellouch J
INSERM U 169, Villejuif, France.
Biometrics. 1992 Jun;48(2):373-88.
Since Pocock (1977, Biometrika 64, 191-199), many methods have been developed for group sequential analysis of clinical trials. However, these methods remain underemployed partly because of inconsistencies of sequential testing [Berry (1987, The Statistician 36, 181-189)]. This paper considers a new approach, which, by requiring that a succession of interim analyses be significant at the alpha level, both preserves the overall significance level alpha and does not present some of the inconsistencies of the previous methods. Results are obtained for a normal or binary response and for survival data. A comparison with the usual group sequential testing is also presented.
自波科克（1977年，《生物统计学》第64卷，第191 - 199页）以来，已经开发出许多用于临床试验组序贯分析的方法。然而，这些方法的应用仍然不足，部分原因是序贯检验存在不一致性[贝里（1987年，《统计学家》第36卷，第181 - 189页）]。本文考虑一种新方法，该方法通过要求一系列中期分析在α水平上具有显著性，既保留了总体显著性水平α，又不存在先前方法的一些不一致性。针对正态或二项响应以及生存数据得出了结果。还给出了与常规组序贯检验的比较。
