This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 189
Type: Invited
Date/Time: Monday, August 2, 2010 : 10:30 AM to 12:20 PM
Sponsor: WNAR
Abstract - #307868
Title: Development of Imaging Biomarkers for Clinical Trials: Applications in Rheumatoid Arthritis
Author(s): Grace S. Park*+
Companies: Amgen Inc.
Address: One Amgen Center Drive, Thousand Oaks, CA, 91320,
Keywords: Imaging ; Biomarker ; Rheumatoid Arthritis ; FDA Critical Path ; Radiograph

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 1 of 3 licensed imaging surrogate biomarkers approved by the US 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. Advancements in imaging techniques like MRI, PET, ultrasonagraphy, and optical spectral transmission, for example, have helped to promote biomarker evaluation with ongoing trials. This poster gives an overview of imaging biomarker development since the precedent of Sharp's criteria in relation to the scope of the FDA's modernization initiative.

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