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Abstract Details

Activity Number: 513
Type: Contributed
Date/Time: Wednesday, August 1, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #306725
Title: Predicting the Event Time in Multicenter Clinical Trials with Time-to-Event Outcome as Primary Endpoint
Author(s): Nibedita Bandyopadhyay*+
Companies: Janssen Pharmaceuticals R&D
Address: 920 Route 202 South, Raritan, NJ, 08869, United States
Keywords: Interim analysis ; multicenter clinical trials ; prediction ; survival analysis

Interim analyses are widely used in Phase II and III clinical trials. The efficiency in drug development process can be improved using interim analyses. In clinical trials with time to an event as primary endpoint, it is common to plan the interim analyses at pre-specified numbers of events. Performing these analyses at times with a different number of events than planned may impact the trial's credibility as well as the statistical properties of the interim analysis. On the other hand, significant resources are required in conducting such analyses. Therefore, for logistic planning purposes, it is very important to predict the timing of this pre-specified number of events early and accurately. A statistical technique for making such prediction in ongoing multicenter clinical trials is developed. Results are illustrated for different scenarios using simulations.

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