This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
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Activity Number:
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627
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Type:
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Contributed
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Date/Time:
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Thursday, August 5, 2010 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308438 |
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Title:
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Statistical Analysis Considerations in Device Trial Planning
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Author(s):
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Helen Marie Chmiel*+ and Kim Perry
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Companies:
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Zimmer, Inc. and Innovative Analytics
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Address:
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1800 W. Center, Warsaw, IN, 46580,
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Keywords:
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Devices ;
Non-inferiority ;
Intent to Treat ;
As Treated ;
Missing Data ;
Sensitivity Analysis
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Abstract:
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Many recommendations have been provided in therapeutic areas to guide in writing the statistical analysis plan but little has been written addressing the particular needs of a device trial. Guidance and scientific literature available when designing and analyzing a clinical trial for a device trial and implications for sample size computations, randomization, writing a statistical analysis plan, and planning final analysis data sets in a non-inferiority trial will be explored. Attention will be given to the current recommendations based on regulatory guidance and research literature when designing the analysis plan for a clinical trial with at least two treatment arms. There will be discussion around the disparity in definition for the analysis datasets (Intent to Treat, Per Protocol, or As Treated) or what analysis population is most appropriate for a non-inferiority trial.
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