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
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Authors
Bekelman, Justin E.Deye, James
Vikram, Bhadrasain
Bentzen, Soren M.
Bruner, Deborah
Curran, Walter J.
Dignam, James
Efstathiou, Jason A.
Fitzgerald, Thomas J.
Hurkmans, Coen
Ibbott, Geoffrey S.
Lee, J. Jack
Merchant, Thomas E.
Michalski, Jeff M.
Palta, Jatinder R.
Simon, Richard
Ten Haken, Randal K.
Timmerman, Robert
Tunis, Sean
Coleman, C. Norman
Purdy, James
Document Type
Journal ArticlePublication Date
2012-07-01Keywords
Clinical Trials as TopicCredentialing
Humans
Multicenter Studies as Topic
National Cancer Institute (U.S.)
Neoplasms
Quality Assurance, Health Care
Quality Improvement
Quality of Life
Radiotherapy Dosage
Research Design
Technology, Radiologic
United States
Neoplasms
Oncology
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Show full item recordAbstract
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.Source
Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):782-90. doi: 10.1016/j.ijrobp.2011.12.080. Epub 2012 Mar 15. Link to article on publisher's siteDOI
10.1016/j.ijrobp.2011.12.080Permanent Link to this Item
http://hdl.handle.net/20.500.14038/47928PubMed ID
22425219Related Resources
Link to Article in PubMedae974a485f413a2113503eed53cd6c53
10.1016/j.ijrobp.2011.12.080
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