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Activity Number:
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43
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Type:
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Invited
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Date/Time:
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Sunday, August 2, 2009 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303091 |
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Title:
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Issues and Challenges in Dichotomizing Continuous Variables in Clinical Trials
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Author(s):
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Qi Jiang*+ and Ivan S.F. Chan
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Companies:
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Amgen, Inc. and Merck & Co., Inc.
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Address:
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, , 91320,
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Keywords:
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Dichotomizing ; Clinical Trial ; Statistically Significant ; Clinically Relevant ; Responder Analysis
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Abstract:
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A clinical trial should be designed to demonstrate not only that an improvement in the primary efficacy endpoint is statistically significant, but also that the magnitude of the effect is clinically relevant. One approach often proposed to ensure that an effect is clinically relevant is a "responder" analysis, in which all subjects are classified as either responders or non-responders based on the value of a continuous outcome variable measured during the trial (or on a change from baseline in that variable). While the responder analysis approach has some appeal, it also has serious disadvantages, such as the often arbitrary nature of the definition of a response. In this presentation we will give an overview of responder analysis commonly seen in different therapeutic areas, and then we will discuss the strengths and weaknesses of this approach.
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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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