Medicine and Health Sciences Commons^™

Joint Modeling Of Treatment Effect On Time-To-Event Endpoint And Safety Covariates In Control Clinical Trial Data Analysis, Kao-Tai Tsai, Karl E. Peace

Biostatistics Faculty Publications

It is a common practice to perform a separate analysis of efficacy and safety data from clinical trials to estimate the benefit and risk aspects of a particular treatment regimen. However, by doing so, one is likely to miss the complete picture of the treatment effect given that these data are generated from the same study subjects and therefore most likely will be correlated. Therefore, it is desirable to analyze these data jointly to obtain a more complete profile of the treatment regimen. A substantial number of statistical methodologies have been proposed in the last decade to model the time-to-event …