Quality Assurance Issues in Conducting Multi-Institutional Advanced Technology Clinical Trials
- Department of Radiation Oncology, University of California, Davis, School of Medicine, Sacramento, CA (United States), E-mail: james.purdy@ucdmc.ucdavis.edu
The National Cancer Institute-sponsored Advanced Technology Quality Assurance (QA) Consortium, which consisted of the Image-Guided Therapy QA Center, Radiation Therapy Oncology Group, Radiological Physics Center, Quality Assurance Review Center, and Resource Center for Emerging Technologies, has pioneered the development of an infrastructure and QA method for advanced technology clinical trials that requires volumetric digital data submission of a protocol patient's treatment plan and verification data. In particular, the Image-Guided Therapy QA Center has nearly 15 years experience in facilitating QA review for Radiation Therapy Oncology Group advanced technology clinical trials. This QA process includes (1) a data integrity review for completeness of protocol required elements, the format of data, and possible data corruption, and recalculation of dose-volume histograms; (2) a review of compliance with target volume and organ-at-risk contours by study chairs; and (3) a review of dose prescription and dose heterogeneity compliance by the Radiation Therapy Oncology Group Headquarters Dosimetry Group or the Radiological Physics Center dosimetrists (for brachytherapy protocols). This report reviews the lessons learned and the QA challenges presented by the use of advanced treatment modalities in clinical trials requiring volumetric digital data submission.
- OSTI ID:
- 21124227
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 71, Issue 1; Conference: 2007 interorganizational symposium on quality assurance of radiation therapy: Challenges of advanced technology, Dallas, TX (United States), 20-22 Feb 2007; Other Information: DOI: 10.1016/j.ijrobp.2007.07.2393; PII: S0360-3016(07)04356-8; Copyright (c) 2008 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
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