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    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
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    UMass Chan Affiliations
    Quality Assurance Review Center
    Department of Radiation Oncology
    Document Type
    Journal Article
    Publication Date
    2012-07-01
    Keywords
    Clinical Trials as Topic
    Credentialing
    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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    http://dx.doi.org/10.1016/j.ijrobp.2011.12.080
    Abstract
    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 site
    DOI
    10.1016/j.ijrobp.2011.12.080
    Permanent Link to this Item
    http://hdl.handle.net/20.500.14038/47928
    PubMed ID
    22425219
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    ae974a485f413a2113503eed53cd6c53
    10.1016/j.ijrobp.2011.12.080
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