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Activity Number:
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646
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 4, 2016 : 8:30 AM to 10:20 AM
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Sponsor:
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Section on Medical Devices and Diagnostics
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Abstract #320925
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Title:
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Multiple Endpoint Evaluation in Diagnostic Medical Imaging: Analyses, Labeling, and Claims
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Author(s):
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Camille Vidal*
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Companies:
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GE Healthcare
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Keywords:
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diagnostic imaging ;
multiple endpoints ;
sequentially rejective procedure ;
labeling
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Abstract:
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It is frequent for diagnostic medical imaging manufacturers to consider several endpoints and sub-populations in the analysis of clinical studies with the intent of obtaining the strongest possible set of clinical claims. In this talk, questions related to the evaluation of multiple endpoints, associated labeling and claims will be presented. In particular the use of multiple hypotheses testing using a graphical method for sequentially rejective procedures and its application to the evaluation of diagnostic medical imaging devices.
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Authors who are presenting talks have a * after their name.
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