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Simulation studies provide an important statistical tool in evaluating survival methods, requiring an appropriate data-generating process to simulate data for an underlying statistical model. Many studies with time-to-event outcomes use the Cox proportional hazard model. While methods for simulating such data with time-invariant predictors have been described, methods for simulating data with time-varying covariates are sorely needed. Here, we describe an approach for generating data for the Cox proportional hazard model with time-varying covariates when event times follow an Exponential or Weibull distribution. For each distribution, we derive a closed-form expression to generate survival times and link the time-varying covariates with the hazard function. We consider a continuous time-varying covariate measured at regular intervals over time, as well as time-invariant covariates, in generating time-to-event data under a number of scenarios. Our results suggest this method can lead to simulation studies with reliable and robust estimation of the association parameter in Cox-Weibull and Cox-Exponential models.

Generating survival times with time-varying covariates using the Lambert W Function