Quality Assurance of Clinical Trials in the Management of Cancer in the Head and Neck

Abstract

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.