The quality assurance groups that support clinical trials have also been restructured. NRG will house CIRO, a center to promote innovative radiation therapy research and intergroup collaboration in radiation.
#Qarc center trial
Boston, MA: ARRS 2009.As a response to recommendations from a report from the Institute of Medicine, NCI is reorganizing it clinical trial groups into a National Clinical Trial Network (NCTN) that consists of four adult groups (Alliance, ECOGACRIN, NRG, and SWOG) and one children’s group (COG). Feasibility of real time diagnostic imaging central review in multicenter cancer trials. Critical impact of radiotherapy protocol compliance and plan quality in the treatment of advanced HNSCC: results from TROG 02.02. Processes for quality improvements in radiation oncology clinical trials. The impact of central quality assurance review prior to radiation therapy on protocol compliance: POG 9426, a trial in pediatric Hodgkin’s disease. Mendenhall NP, Meyer J, Williams J, et al. Real time diagnostic imaging central review and radiotherapy interventional review in multicenter cancer trials.
Randomized study of intensive MOPP-ABVD with or without low-dose total-nodal radiation therapy in the treatment of stages IIB, IIIA2, IIIB, and IV Hodgkin’s disease in pediatric patients: a Pediatric Oncology Group study. Weiner MA, Leventhal B, Brecher ML, et al. Dosimetric considerations for validation of a sequential IMRT process with a commercial treatment planning system. Design and implementation of an anthropomorphic quality assurance phantom for intensity-modulated radiation therapy for the Radiation Therapy Oncology Group. Implementation of ATC method 1 for clinical trials data review at the Quality Assurance Review Center. CERR: a computational environment for radiotherapy research.
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. Recent evidence demonstrates that compliance to study guidelines may have significant influence on study and patient outcome. 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. 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. 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. 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. Integrating tissue analysis and imaging strategies in clinical trial objectives is an important area of clinical translational research.
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