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Activity Number:
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184
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 4, 2008 : 2:00 PM to 3:50 PM
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Sponsor:
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WNAR
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| Abstract - #302177 |
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Title:
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Imaging Endpoints for Clinical Trials: The Sharp Score for Radiographic Data in Rheumatoid Arthritis
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Author(s):
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Grace S. Park*+
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Companies:
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Amgen, Inc
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Address:
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One Amgen Center Dr., Thousand Oaks, CA, 91320,
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Keywords:
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Biomarker ; Rheumatoid Arthritis ; Radiograph ; FDA
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Abstract:
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Imaging is an important tool used to assess and accelerate the process of therapeutic options in clinical medicine. Sharp's criteria for rheumatoid arthritis form just one of three licensed imaging surrogate biomarkers approved by the US Food and Drug Administration (FDA). Along with imaging used in oncology research, the Sharp score serves as a biomarker that reveals the extent and severity of disease using standard radiographs. However, in response to drug development programs and advancements in imaging techniques, the FDA issued its critical path initiative in 2004. Seeking to advance biomarker technologies, it promoted the integration of biomarker evaluation with ongoing trials to reduce development expenses. This presentation gives an overview of the precedent of Sharp's criteria in relation to the scope of the FDA's modernization initiative.
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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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