POSB387 Leveraging Real-World Data for Time-to-Event Endpoints in Clinical Trials

Use of Real-World Data (RWD) to augment evidence in clinical trials is often constrained by the type of endpoints considered. Particular limitations arise for Time-to-Event (TTE) endpoints where there are differences in missing events between trial data and RWD, definition of “time zero”, reporting bias, immortal time bias, among others. This research focuses on the problem of time zero in RWD, reviews currents methods to address this challenge, and makes recommendations.