Abstract

The charge of AAPM Task Group 113 is to provide guidance for the physics aspects of clinical trials to minimize variability in planning and dose delivery for external beam trials involving photons and electrons. Several studies have demonstrated the importance of protocol compliance on patient outcome. Minimizing variability for treatments at different centers improves the quality and efficiency of clinical trials. Attention is focused on areas where variability can be minimized through standardization of protocols and processes through all aspects of clinical trials. Recommendations are presented for clinical trial designers, physicists supporting clinical trials at their individual clinics, quality assurance centers, and manufacturers.

Highlights

  • INTRODUCTION AND CHARGE OF THE REPORTThere is growing evidence[1,2,3,4,5] on the need for standardization of treatment planning and delivery methods to ensure quality in clinical trials to help support the investigation of new safe and effective treatments and/or assessment methods in multi-institutional settings

  • Such standardization will improve the consistency of the radiotherapy received by patients and the radiotherapy data submitted for a given clinical trial

  • A related consideration that affects overall quality is the ability of those participating in clinical trials to create plans as part of their standard clinical flow that are both compliant with protocol specifications and optimal

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Summary

Introduction

INTRODUCTION AND CHARGE OF THE REPORTThere is growing evidence[1,2,3,4,5] on the need for standardization of treatment planning and delivery methods to ensure quality in clinical trials to help support the investigation of new safe and effective treatments and/or assessment methods in multi-institutional settings. Improved planning tools such as those with knowledge-based planning have been needed for some time to provide detailed feedback to institutions on whether or not their treatment plans meet the dose-volume histogram requirements but are optimal for use in clinical trials.

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