APPLICATION OF THE TRIANGULAR TEST TO PHASE-II CANCER CLINICAL-TRIALS

被引:41
作者
BELLISSANT, E
BENICHOU, J
CHASTANG, C
机构
[1] Departement de Biostatistique et Informatique Medicale, Hopital Saint-Louis, Paris, 75475, avenue Claude Vellefaux
关键词
D O I
10.1002/sim.4780090807
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
Phase II cancer clinical trials are primarily designed to determine whether the response rate p to the treatment under study is greater than a specified value p0, that is to test the null hypothesis H0: p < p0 against an alternative hypothesis H1: p > p0 specified by p = p1. As an alternative to the single and multistage procedures and to Wald's continuous sequential probability ratio test (SPRT), we applied the group sequential methods proposed by Jones and Whitehead, namely the triangular test (TT) and the discrete SPRT, to the comparison of p with p0, and we expressed H0 and H1 in terms of the log odds‐ratio statistic log [p(1 — p0)/Po(1 — p)]. A simulation study showed that both the TT and the discrete SPRT had type I error and power close to the nominal values, and they compared favourably with multistage methods in terms of the average sample size. Copyright © 1990 John Wiley & Sons, Ltd.
引用
收藏
页码:907 / 917
页数:11
相关论文
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