Abstract Details
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Activity Number:
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304
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Type:
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Contributed
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Date/Time:
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Tuesday, August 6, 2013 : 8:30 AM to 10:20 AM
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Sponsor:
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Biometrics Section
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| Abstract - #308754 |
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Title:
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Use of Mixed-Effect Models in Optimization of Risk-Based Monitoring of Multicenter Trials
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Author(s):
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Xiaoqiang Xue*+ and Valerii Fedorov
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Companies:
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and Quintiles
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Keywords:
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Risk Based Monitoring ;
Poisson-Gamma ;
risk function ;
randomized Monitoring
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Abstract:
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Following Guideline from FDA and EMEA, Risk Based Monitoring (RBM) aims to enhance human subject protection and clinical trial data quality while reducing clinical research cost. Our approach is based on the Poisson-Gamma mixed effect model and we derive a decision rule that minimizes the risk function associated with randomized monitoring. Our major target is monitoring of Adverse Events and Protocol Deviations, two critical data domains representing patient safety and protocol compliance during clinical trials.
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Authors who are presenting talks have a * after their name.
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