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Activity Number:
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62
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Type:
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Topic Contributed
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Date/Time:
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Sunday, July 29, 2007 : 4:00 PM to 5:50 PM
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Sponsor:
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WNAR
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| Abstract - #309732 |
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Title:
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Meta-Analysis of Clinical Trial Safety Data in Rheumatoid Arthritis (RA) and Other Inflammatory Disease
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Author(s):
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Yun Chon*+ and Hong A. Xia
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Companies:
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Amgen Inc. and Amgen Inc.
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Address:
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MS 24 2 C, Thousand Oaks, CA, 91320,
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Keywords:
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Rare Adverse Event ; Safety Data ; Meta-Analysis ; Poisson model
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Abstract:
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Most of clinical trials are designed based on efficacy end points, and therefore have limited power to detect important differences in safety endpoints. The detection of rare AEs is more problematic since studies have relatively short periods and AEs often sparse and leading to zero event in one or both treatment groups. A meta-analysis can be conducted to detect the differences in rare AE between two treatment groups. Results of meta-analysis may be sensitive to the choice of statistical methods. Sensitivity analyses to assess the robustness of results are recommended. The meta-analysis methods at the aggregated study level and at individual patient level using Poisson models and survival techniques are illustrated using clinical trial data. Individual patient data analysis with an appropriate choice of covariates is a preferred method.
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