Joint Modeling of the Treatment Effect in Clinical Trials with Time-to-Event Endpoint and Safety Covariates

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Proceedings of the Biopharmaceutical Section of the American Statistical Association


It is common practice in clinical trials to analyze efficacy and safety data separately to estimate the benefit and risk aspects of a particular treatment regimen. However, given that these data are generated from the same study subjects and therefore are likely correlated, one may miss the complete picture of the treatment effect by separate analyses of efficacy and safety data. Therefore, it is desirable to jointly analyze these data 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 time-to-event data and longitudinal repeated measures jointly. These methods provide better insight to understand the treatment effect in time-to-event data by incorporating the information contained in the longitudinal repeated measures.

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