This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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345
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Type:
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Contributed
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Date/Time:
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Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #307648 |
Title:
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Random Delayed Effects and the Power of the Unweighted Log-Rank Test in Survival Trials
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Author(s):
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Jonathan Siegel*+
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Companies:
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Bristol-Myers Squibb
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Address:
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5 Research Parkway, Wallingford, CT, 06492,
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Keywords:
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Survival Analysis ;
Non-Proportional Hazards ;
Delayed Effect ;
Random Delay ;
Log-Rank Test
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Abstract:
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Clinical survival trials traditionally assume piece-wise constant hazards with fixed change points. Novel classes of immunotherapy cancer treatments have biological mechanisms of action suggesting a variable delayed effect. This paper focuses on the effects of random delay on the power of the unweighted log-rank test. It proposes a random time-to-repair approach, analogous to system-component failure bivariate interaction mixture models, in which drug effect delay is modeled as a Poisson signal whose onset reduces the hazard. The model is shown to be more powerful for finite observation periods than a two-compartment fixed delayed-effect model with the same true mean delay. The effects of random delay on power vis-a-vis constant hazards, fixed delay, and Weibull models are simulated. Problems of delayed effects in survival trial design and in regulatory use are discussed.
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Authors who are presenting talks have a * after their name.
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