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Abstract Details
Activity Number:
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245
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Type:
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Contributed
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Date/Time:
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Monday, July 30, 2012 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #304326 |
Title:
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The Stochastic Curtailment of Long-Term Clinical Trials for Noninferiority Case vs. Superiority Case and Its Visualization
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Author(s):
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Shaoyi Li*+
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Companies:
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Celgene Corporation
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Address:
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62 Briarwood Drive East, Warren, NJ, 07059, United States
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Keywords:
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non-inferiority ;
stochastic curtailment ;
conditional power ;
interim analysis ;
futility ;
data monitoring
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Abstract:
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The stochastic curtailment of long-term clinical trials (either sequential or non-sequential) is considered. The conditional means of the B-value at the end of trial given the B-value at interim under different assumptions about the remainder of trial in the context of normally distributed data are analyzed to reveal the quantitative connection between non-inferiority and superiority. The corresponding analytical form of critical B-value or the slope of the trend for stopping the trial at interim for futility is also provided for non-inferiority case. Several useful properties are provided to quantify the lower hurdle of non-inferiority comparing against superiority case. Furthermore, the projection of stochastic curtailment for non-inferiority case is superimposed with the superiority case to illustrate the natural relationship between them. The results are applicable to asymptotically normal such as censored survival data and binomial data.
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Authors who are presenting talks have a * after their name.
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