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Activity Number: 232
Type: Topic Contributed
Date/Time: Monday, August 10, 2015 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #314776 View Presentation
Title: Unblinded Sample-Size Reassessment in Time-to-Event Clinical Trials
Author(s): Dominic Magirr*
Companies:
Keywords: Adaptive clinical trials ; Sample Size Re-estimation ; time-to-event
Abstract:

Mid-study design modifications are becoming increasingly accepted in confirmatory clinical trials, so long as appropriate methods are applied such that error rates are controlled. It is therefore unfortunate that the important case of time-to-event endpoints is not easily handled by the standard theory. We analyze current methods that allow design modifications to be based on the full interim data, i.e., not only the observed event times but also secondary endpoint and safety data from patients who are yet to have an event. We show that the final test statistic may ignore a substantial subset of the observed event times, and that this leads to inefficiency compared to alternative sample size re-estimation strategies.


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