This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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328
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #307189 |
Title:
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Multiplicity Issues in Meta-Analyses to Rule Out an Unacceptable Cardiovascular Risk
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Author(s):
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Stefan Hantel*+
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Companies:
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Boehringer Ingelheim Pharmaceuticals, Inc.
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Address:
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Birkendorfer Str. 65, Biberach, 88400 , Germany
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Keywords:
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Multiplicity ;
Meta-analysis ;
diabetes ;
cardiovascular risk
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Abstract:
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The traditional development program for an anti-diabetic drug includes several trials of 24 weeks treatment duration. These trials may not provide sufficient data to rule out an unacceptable cardiovascular risk according to the FDA guideline under the assumption that the true hazard ratio is about 1.0. This presentation discusses strategies to fulfill the requirements of the guideline at time of completion of the phase III program or as soon as possible thereafter with the goal to show that the upper confidence limit of the hazard ratio is below 1.8. The strategy covers also the ultimate goal to show that the confidence interval is below 1.3 at time of submission or after approval of the drug. Meta-analysis techniques accounting for multiple analyses over time will be presented. These strategies should include the option to modify the time points of the analyses based on phase III data.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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