Global Harmonization of Quality Assurance Naming Conventions in Radiation Therapy Clinical Trials

Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1242-9. doi: 10.1016/j.ijrobp.2014.08.348.

Abstract

Purpose: To review the various radiation therapy quality assurance (RTQA) procedures used by the Global Clinical Trials RTQA Harmonization Group (GHG) steering committee members and present the harmonized RTQA naming conventions by amalgamating procedures with similar objectives.

Methods and materials: A survey of the GHG steering committee members' RTQA procedures, their goals, and naming conventions was conducted. The RTQA procedures were classified as baseline, preaccrual, and prospective/retrospective data capture and analysis. After all the procedures were accumulated and described, extensive discussions took place to come to harmonized RTQA procedures and names.

Results: The RTQA procedures implemented within a trial by the GHG steering committee members vary in quantity, timing, name, and compliance criteria. The procedures of each member are based on perceived chances of noncompliance, so that the quality of radiation therapy planning and treatment does not negatively influence the trial measured outcomes. A comparison of these procedures demonstrated similarities among the goals of the various methods, but the naming given to each differed. After thorough discussions, the GHG steering committee members amalgamated the 27 RTQA procedures to 10 harmonized ones with corresponding names: facility questionnaire, beam output audit, benchmark case, dummy run, complex treatment dosimetry check, virtual phantom, individual case review, review of patients' treatment records, and protocol compliance and dosimetry site visit.

Conclusions: Harmonized RTQA harmonized naming conventions, which can be used in all future clinical trials involving radiation therapy, have been established. Harmonized procedures will facilitate future intergroup trial collaboration and help to ensure comparable RTQA between international trials, which enables meta-analyses and reduces RTQA workload for intergroup studies.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Advisory Committees
  • Benchmarking / standards
  • Clinical Trials Data Monitoring Committees / standards*
  • Clinical Trials as Topic / standards*
  • Credentialing
  • Humans
  • Organizational Objectives
  • Phantoms, Imaging
  • Quality Assurance, Health Care / standards*
  • Radiotherapy / standards*
  • Radiotherapy Dosage
  • Radiotherapy Planning, Computer-Assisted / standards*
  • Radiotherapy, Image-Guided / standards
  • Surveys and Questionnaires / standards
  • Terminology as Topic*