Redesigning Radiotherapy Quality Assurance: Opportunities to Develop an Efficient, Evidence-Based System to Support Clinical Trials-Report of the National Cancer Institute Work Group on Radiotherapy Quality Assurance

Journal Article · Sun Jul 01 00:00:00 EDT 2012 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/J.IJROBP.2011.12.080· OSTI ID:22058875

Deye, James A; Vikram, Bhadrasain ^[1]; Bentzen, Soren M ^[2]; Bruner, Deborah ^[3]; Curran, Walter J ^[4]; Dignam, James ^[5]; Efstathiou, Jason A ^[6]; FitzGerald, T J ^[7]; Hurkmans, Coen ^[8]; Ibbott, Geoffrey S; Lee, J Jack ^[9]; Merchant, Thomas E ^[10]; Michalski, Jeff ^[11]; Palta, Jatinder R ^[12]; Simon, Richard ^[13]; Ten Haken, Randal K ^[14]; Timmerman, Robert ^[15]; Tunis, Sean ^[16]; Coleman, C Norman ^[1]; others, and

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1. National Cancer Institute, Bethesda, Maryland (United States)
2. University of Wisconsin, Madison, Wisconsin (United States)
3. University of Pennsylvania, Philadelphia, Pennsylvania (United States)
4. Emory University, Atlanta, Georgia (United States)
5. University of Chicago, Chicago, Illinois (United States)
6. Massachusetts General Hospital, Boston, Massachusetts (United States)
7. University of Massachusetts, Boston, Massachusetts (United States)
8. European Organization for Research and Treatment of Cancer, Brussels (Belgium)
9. University of Texas MD Anderson Cancer Center, Houston, Texas (United States)
10. St. Jude Children's Research Hospital, Memphis, Tennessee (United States)
11. University of Washington, St. Louis, Missouri (United States)
12. University of Florida, Miami, Florida (United States)
13. National Institutes of Health, Bethesda, Maryland (United States)
14. University of Michigan, Ann Arbor, Michigan (United States)
15. University of Texas Southwestern Medical Center, Dallas, Texas (United States)
16. Center for Medical Technology Policy, Baltimore, Maryland (United States)

Purpose: In the context of national calls for reorganizing cancer clinical trials, the National Cancer Institute sponsored a 2-day workshop to examine challenges and opportunities for optimizing radiotherapy quality assurance (QA) in clinical trial design. Methods and Materials: Participants reviewed the current processes of clinical trial QA and noted the QA challenges presented by advanced technologies. The lessons learned from the radiotherapy QA programs of recent trials were discussed in detail. Four potential opportunities for optimizing radiotherapy QA were explored, including the use of normal tissue toxicity and tumor control metrics, biomarkers of radiation toxicity, new radiotherapy modalities such as proton beam therapy, and the international harmonization of clinical trial QA. Results: Four recommendations were made: (1) to develop a tiered (and more efficient) system for radiotherapy QA and tailor the intensity of QA to the clinical trial objectives (tiers include general credentialing, trial-specific credentialing, and individual case review); (2) to establish a case QA repository; (3) to develop an evidence base for clinical trial QA and introduce innovative prospective trial designs to evaluate radiotherapy QA in clinical trials; and (4) to explore the feasibility of consolidating clinical trial QA in the United States. Conclusion: Radiotherapy QA can affect clinical trial accrual, cost, outcomes, and generalizability. To achieve maximum benefit, QA programs must become more efficient and evidence-based.

• OSTI ID: 22058875
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Vol. 83, Issue 3; Other Information: Copyright (c) 2012 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

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
BIOLOGICAL MARKERS
CLINICAL TRIALS
METRICS
NEOPLASMS
OPTIMIZATION
PROTON BEAMS
QUALITY ASSURANCE
RADIOTHERAPY
TOXICITY