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Abstract Details
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Activity Number:
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192
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Type:
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Roundtables
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Date/Time:
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Monday, August 1, 2011 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #300755 |
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Title:
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Implementation and Logistics of Adaptive Trial Design
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Author(s):
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Eva R. Miller*+
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Companies:
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ICON Clinical Research
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Address:
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212 Church Rd, North Wales, PA, 19454, USA
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Keywords:
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Adaptive Trial Design
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Abstract:
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Participants at this roundtable will discuss real world experiences in the implementation of adaptive trials. Statisticians who have actually conducted adaptive trials are welcome. as are statisticians who are about to conduct adaptive trials for the first time.. Topics include: roles and responsibilities of the unblinded statistician, communication paths to preserve trial integrity, data lag, working with several data sources, and managing randomization and drug supply within IVRS.
Study teams experience greater demands for planning, communication and teamwork within adaptive trial designs than for traditional trials. We will discuss how these demands impact the statisticians, SAS programmers, Project Managers, data managers, and drug supply managers. Hopefully, participants will be better prepared to surmount the hurdles.
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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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