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Activity Number:
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103
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 3, 2009 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303981 |
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Title:
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Performance Characteristic of a Confidence Interval Approach for Safety Data Monitoring
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Author(s):
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Huyuan Yang*+ and Haiying Lin and Hiroshi Fujimoto
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Companies:
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Boston Scientific Corporation and Boston Scientific Corporation and Boston Scientific Japan K.K
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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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safety monitor ; sumulation ; safety threshold
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Abstract:
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For post-approval trial, the sponsor is required to monitor the safety profile of the on-going trial based on the historical acceptable rates established in the pre-approval trials. For pre-approval trial, the safety profile based on literatures and control rate should also be monitored. A simple confidence interval approach using the acceptable rate is developed for safety monitoring. Two safety triggers are proposed for the safety data monitoring. The safety watch and safety alert triggers are calculated from the upper 2-sided 80% and 95% confidence limits, respectively. If the event rate exceeds the trigger, an appropriate investigation will be deployed. A case study using the historical data to establish the acceptable rates for clinical outcomes and specific time intervals will be presented. The performance characteristic of such approach will be discussed using simulated data.
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