21: A novel resampling technology of time-to-event outcome for trial simulation

Music City Center 

A method for resampling patients from historical trial for the time-to-event outcome is lacked which is a quite common endpoint of interest in some studies. In the current practice, simulating patient level data with time-to-event outcome is fully assumption based and can be easily suspected and challenged. Therefore, resampling patient level data directly from historical clinical trial is closer to the real collected data structure and can preserve the distribution of outcome and the correlations across covariates (both baseline and postbaseline) in the simulated datasets. A novel algorithm is developed that can draw patient level samples from historical clinical trials with time-to-event outcome, given the targeted number of events, sample size and incident rate per user defined. The simulated samples will preserve the same distribution shape to the original dataset and can be used in the downstream trial simulations. Our proposed algorithm can be broadly applied to studies with time-to-event endpoint to support study design and analysis plan.

time-to-event

simulation

clinical trial 

Biopharmaceutical Section