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Activity Number:
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412
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 5, 2009 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305831 |
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Title:
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Bumps in the Road for an Academic Data Coordinating Center
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Author(s):
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William R. Clarke*+ and Dixie Ecklund and Ying Zhang
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Companies:
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The University of Iowa and The University of Iowa and The University of Iowa
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Address:
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Clinical Trials Statistical and Data Management Center, Iowa City, IA, 52242,
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Keywords:
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Data Coordinating Center ; Futility Analysis
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Abstract:
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The Clinical Trials Statistical and Data Management Center is a center within the Department of Biostatistics at The University of Iowa. Like many other academic centers, we support NIH funded clinical trials and a large multi disciplinary consortium. In the past 5 years we have encountered many bumps in the road that presented critical challenges to our role as a data center. Substantial growth has presented organizational challenges. A new study required that our electronic data capture and data management systems be certified as 21 CRF part 11 compliant. Slow recruitment let to a need for developing futility methods for both outcome and for recruitment. This presentation will describe our successes and failures. We will also describe novel methods for presenting futility recommendations to a DSMB for both outcome and recruitment.
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