LAUSR

ABSTRACT Sample size determination is essential during the planning phases of a study. When the study endpoint is the time to an event, Cox proportional hazard model is the traditional technique to analyze the effects of covariates on survival time. In contrast to the proportional hazard model, the additive hazard (AH) model specifies that the effect of covariates additively increases or decreases the hazard function. The popularity of this model is that it gives a more intuitive interpretation without the proportional hazard assumption. Because there is no literature estimating the required sample size based on the AH model, we provide a flexible formula for calculating the required sample size. The proposed formula incorporates time-independent and time-dependent effects of covariates without complicated mathematical calculations. The performance of the method was evaluated by extensive simulations. Finally, some pilot studies are shown to illustrate the applications.