Quality Assurance for Multi-Institutional Clinical Trials

Abstract

The need for specific quality assurance (QA) activities in the framework of clinical trials is continually increasing as the technical requirements needed for optimal radiation oncology continue to evolve and to become more demanding as new technologies continue to be developed and implemented at a progressively higher rate. The need for exchange of digital data allowing the evaluation of volume delineation and dose-volume parameters and enabling the linking of these QA parameters to the clinical outcome has led to the development of dedicated technical platforms and software for clinical trials QA. All of these developments present credentialing and QA challenges for cooperative groups and clinical trial QA centers. The level of appropriate QA in clinical trials is highly dependent on the complexity of the trial. It should be evidence based; by doing this, efficient QA in clinical trials will improve the overall quality of treatment for most patients at an acceptable cost. It is also apparent that clinical trials are becoming much more multicenter, multidisciplinary and international, thereby not only giving additional relevance to the already stringent demands for QA but also putting forward the critically important issue of harmonization of clinical trials credentialing and QA procedures. This chapter will address all these issues focusing primarily on the United States and European clinical trial QA experience.