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A microcomputer program for the design and analysis of phase II cancer clinical trials with two group sequential
E Bellissant1, J Benichou, C Chastang
1Département de Biostatistique et Informatique Médicale, Hôpital Saint-Louis, Paris, France.
Abstract:
We developed an interactive and menu-driven computer program to help investigators design and analyze phase II cancer clinical trials with a group sequential method, namely the sequential probability ratio test or the triangular test. Based on the values selected for the parameters of the trial, the "Design" option allows one to obtain, using simulations, the statistical properties (type I and II error rates and the probability that the test accepts the hypothesis of inefficacy under 21 different assumptions) and the average sample size (under the same assumptions) of the selected test. The "Analysis" option (i) computes, at each analysis, the two statistics V and Z on which the sequential method is based and plots the sample path from the number of successes observed, and (ii), using asymptotic properties, gives the significance level of the test and a point estimate (with its 95% confidence interval) of the parameter of interest at the last analysis.