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Activity Number: 133
Type: Contributed
Date/Time: Monday, August 1, 2016 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #319893 View Presentation
Title: Evaluation of Adaptive Sequential Designs in the Setting of Anticipated Crossing Survival
Author(s): William Koh* and Scott Emerson
Companies: University of Washington and University of Washington
Keywords: group sequential ; crossing survival ; composite statistic ; crossing hazards ; time varying treatment ; data monitoring committee
Abstract:

In a time to event clinical trial, researchers may posit the possibility that survival curves may cross at some time point. Logan et al. (2008), Logan and Mo (2015) considered the analysis of censored time to event data with the objective of detecting the "better" treatment when crossing survival curves are quite plausible. We investigate the alternatives used by Logan et al's composite statistics, and use simulations to assess how their test statistics behave under the setting of non proportional hazards, both with stochastically ordered and with potentially crossing survival. We further investigate the behavior of the alternative test statistics as a function of the censoring distribution. We then examine how this may impact any sequential designs where a DMC may make an interim decision to stop the trial early or adapt trial parameters based on unanticipated differences in survival. We find little advantage to the use of Logan et al's proposed composite statistics over judicious choice among the commonly used test statistics in the sequential survival setting.


Authors who are presenting talks have a * after their name.

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