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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227
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 2, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #307138 |
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Title:
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Performance Characteristic of Sequential Probability Ratio Test (SPRT) for Data Monitoring Committee (DMC) Review in Drug-Eluting Stent Clinical Trials
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Author(s):
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Yun Lu*+ and Huyuan Yang
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Companies:
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Boston Scientific Corporation and Boston Scientific Corporation
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Address:
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100 Boston Scientific Way, Marlborough, MA, 01752,
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Keywords:
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Sequential Probability Ratio Test (SPRT) ;
Data Monitoring Committee (DMC) ;
safety alert ;
drug-eluting stent
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Abstract:
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Data Monitoring Committee (DMC) review is required for clinical trials. DMC monitors patient safety and treatment efficacy data in ongoing trials. One of the tools to monitor dynamic safety events is Sequential Probability Ratio Test (SPRT).The thresholds for the SPRT stopping guideline are determined by the acceptable rate, unacceptable rate, type I error and type II error. A safety alert will be triggered if the event rate exceeds the SPRT stopping boundary. The performance characteristics of SPRT will be discussed using simulation data with different acceptable rate, unacceptable rate and number of patient at risk.
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Authors who are presenting talks have a * after their name.
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