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Abstract Details
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Activity Number:
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660
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Type:
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Contributed
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Date/Time:
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Thursday, August 2, 2012 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305736 |
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Title:
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Decision Rule Based on a Noninferiority Trial
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Author(s):
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Madhuja Mallick*+
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Companies:
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Forest Laboratories Inc
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Address:
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, , , United States
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Keywords:
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Abstract:
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In clinical trials, a placebo-controlled trial is common to demonstrate medical efficacy and safety/tolerability of the treatment of interest. However to demonstrate the treatment of interest is not worse than the already marketed treatment in the disease area, a non-inferiority trial can be appropriate. Non-inferiority trials often suffer from some challenges in their design. This presentation will discuss some challenges in carrying out a non-inferiority trial with clinical trial examples. It is also of interest to quantitatively estimate the probability of success. There are various means of accomplishing this: simple frequentist methods, Bayesian approaches. Bayesian methods would weight prior information and beliefs alongside data generated from the earlier trials in a model-based approach. Examples of such procedures will be demonstrated via simulation using a clinical trial example.
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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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