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Activity Number:
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528
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 2, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Section on Statistics in Epidemiology
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| Abstract - #309170 |
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Title:
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On Design Issues of Clinical Studies for in vitro Diagnostics
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Author(s):
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Christoph Berding*+
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Companies:
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Roche Diagnostics GmbH
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Address:
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Nonnenwald 2, Penzberg, 82377, Germany
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Keywords:
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diagnostic ; design ; study
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Abstract:
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We review selected medical situations, where diagnostic tools support medical decision making. IVD manufacturers screen these medical areas for useful new proteomic or genomic markers or marker panels. Accordingly a new marker project starts with the formulation of a medical need and the intended use of the new diagnostic tool. Additionally clinical studies to demonstrate the performance and clinical utility of the new markers/marker panels have to be defined. Depending on project advancement these studies are either explanatory or confirmatory in nature. In early phases diagnostic studies are often retrospective case-control, which requires a careful investigation into all kinds of bias. By way of example we discuss a number of diagnostic settings and related study designs. Rather than presenting ready-to-use design solutions we would like stimulate the discussion on alternatives.
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