Sample size determination in superiority or non-inferiority clinical trials with time-to-event data under exponential, Weibull and Gompertz distributions

Abstract

To examine the effect of exponential, Weibull and Gompertz distributions on sample size determination for superiority trials (STs) or non-inferiority trials (NTs) with time-to-event data based on proportional hazard model, we present two sample size formulas for STs or NTs based on Weibull and Gompertz distributions, respectively. The formulas are compared with the current exponential formula to examine their performance. The simulation results show that the sample size formula based on the Weibull distribution is the most robust among the three formulas in STs or NTs. We suggest that recognizing the appropriate distribution in advance is beneficial for proper project planning and that assuming a Weibull distributed survival time is most advantageous in STs or NTs.