Quality Assurance of Clinical Trials in the Management of Cancer in the Head and Neck
Springer eBooks(2011)
摘要
Integrating tissue analysis and imaging strategies in clinical trial objectives is an important area of clinical translational
research. Clinical trial designs that incorporate clear guidelines for clinical trial execution, definitions of data submission
pathways and study deviations, and integration of real time and adaptive quality assurance will provide uniformity of study
populations for clinical trial analysis. Essential to clinical trials management is a robust, validated informatics platform
to display data and imaging in a uniform manner acquired from diverse platforms and re-presented for both on site and distributed
review in a uniform file format. The Quality Assurance Review Center (QARC) uses a robust informatics platform to provide
protocol development, site credentialing, data acquisition, case management, capable of both real time and retrospective review
of objects, data transfer to clinical trial sponsor and/or industry partner and data archiving. As a member of the Virtual
Imaging Evaluation Workspace (VIEW) and the Advanced Technology Quality Assurance (QA) Consortium (ATC), QARC collaborates
in the development, sharing and implementation of credentialing tools, digital acquisition and review tools and processes,
a common platform for data storage for radiotherapy and imaging with emphasis on compliance to caBIG and 21 CFR Part 11. Recent
evidence demonstrates that compliance to study guidelines may have significant influence on study and patient outcome. Head
and neck cancer is a very good area to study biopharmacology of treatment response and the quality assurance process is a
vehicle for adaptive clinical trial and patient management.
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关键词
compliancereal-time reviewquality assur- anceinformaticsclinical trialcredentialingqa
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