Abstract Details
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Activity Number:
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163
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 5, 2013 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308828 |
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Title:
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A Brief Overview of the Draft Enrichment Guidance
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Author(s):
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Boguang Zhen*+
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Companies:
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FDA
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Keywords:
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enrichment ;
guidance ;
overview
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Abstract:
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The U.S. Food and Drug Administration released the draft guidance for industry "Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products" recently. The term enrichment is defined as the prospective use of any patient characteristic to select a study population in which detection of a drug effect if present is more likely than it would be in an unselected population. This talk will give a brief overview of the draft guidance including the rationales, the kinds of enrichment, and the study design considerations. The pros and cons, and the cautions with use of such strategies will be discussed.
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Authors who are presenting talks have a * after their name.
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