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Activity Number:
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431
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 6, 2008 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301488 |
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Title:
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Supporting the DMC To Fulfill Their Responsibilities Through Clear, Comprehensive, and Carefully Constructed Reports on Accumulating Interim Data
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Author(s):
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Marian R. Fisher*+
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Companies:
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University of Wisconsin-Madison
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Address:
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610 Walnut Street, WARF Room 215, Sch of Med & Pub Hlth, Madison, WI, 53726,
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Keywords:
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data monitoring committee ; independent statistical data analysis center ; interim monitoring ; DMC reports ; incomplete event adjudication ; blinded sample size change
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Abstract:
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Interim data inherently require thought in terms of integration of various sources for timeliness, availability, cleanliness, and consistency. Making a decision to have a DMC evaluate accumulating interim data for safety and efficacy requires preparation of reports based on interim data. Members of the DMC include clinicians and others with collaborative research expertise so DMC reports must be constructed to present analysis results effectively and efficiently. Examples of analysis of time-to-event data with incomplete event adjudication and of a change in sample size in a blinded fashion that allowed flexibility and preserved the overall type I error rate will be presented.
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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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