Sample size calculations for the log rank test: a Gompertz model approach

Abstract

Sample size calculations for clinical trials dealing with survivorship are often based on an exponential model. This model is inappropriate when a non-zero proportion of the population is expected to have indefinite survival. In such cases the Gompertz model offers a reasonable alternative. A method for calculating the required accrual time for a clinical trial in which the treatment arms have Gompertz survival distributions satisfying the proportion hazards assumption is developed. A computer program to perform this method is given, as well as an iterative method that can be used when a computer is not available.