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Abstract Details
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Activity Number:
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160
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 1, 2011 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #302315 |
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Title:
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Adaptive Design: Some Theories and Examples
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Author(s):
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Xiaolong Luo*+
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Companies:
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Celgene Corporation
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Address:
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86 Morris Avenue, Summit, NJ, ,
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Keywords:
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adaptive design ;
clinical trial ;
type 1 error
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Abstract:
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While the concept of adaptive design for clinical trials has become well known through many recent publications and regulatory guidance, what is less recognized is its evolutional impact on general statistical framework and methodology, which attributes to some well known controversies in its applications. In this talk, we will explain how the commonly used statistics methodology is built on i.i.d. observations and why that assumption may not be sufficient for many clinical trials. We will introduce our recently developed statistical method that overcomes the typical i.i.d. limitation and naturally fits with adaptive design. We will use numerical examples and a completed adaptive clinical trial to evaluate the performance of the method in traditional criteria such as bias and type 1 error rate.
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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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