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Activity Number:
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175
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Type:
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Roundtables
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Date/Time:
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Monday, August 3, 2009 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303440 |
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Title:
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Data-Monitoring Committees: What Is the Scope of the Information the DMC Can Review?
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Author(s):
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Dennis W. King*+
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Companies:
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STATKING Consulting, Inc.
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Address:
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759 Wessel Drive, Fairfield, OH, 45014,
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Keywords:
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Data Monitoring Committees ; Data Safety Monitoring Boards
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Abstract:
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This roundtable will discuss the operation of data monitoring committees in industry sponsored clinical trials. Specifically, the question of what data and information can be reviewed and considered by a data monitoring committee in making decisions concerning the clinical trial will be addressed. The legal, ethical and practical aspects of data monitoring committee recommendations to the sponsor company will be discussed.
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