The weighted log-rank class under truncated binomial design: saddlepoint p-values and confidence intervals

Abstract

The randomization design used to collect the data provides basis for the exact distributions of the permutation tests. The truncated binomial design is one of the commonly used designs for forcing balance in clinical trials to eliminate experimental bias. In this article, we consider the exact distribution of the weighted log-rank class of tests for censored data under the truncated binomial design. A double saddlepoint approximation for p-values of this class is derived under the truncated binomial design. The speed and accuracy of the saddlepoint approximation over the normal asymptotic facilitate the inversion of the weighted log-rank tests to determine nominal 95% confidence intervals for treatment effect with right censored data. © 2011 Springer Science+Business Media, LLC.