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dc.contributor.authorBekelman, Justin E.
dc.contributor.authorDeye, James
dc.contributor.authorVikram, Bhadrasain
dc.contributor.authorBentzen, Soren M.
dc.contributor.authorBruner, Deborah
dc.contributor.authorCurran, Walter J.
dc.contributor.authorDignam, James
dc.contributor.authorEfstathiou, Jason A.
dc.contributor.authorFitzgerald, Thomas J.
dc.contributor.authorHurkmans, Coen
dc.contributor.authorIbbott, Geoffrey S.
dc.contributor.authorLee, J. Jack
dc.contributor.authorMerchant, Thomas E.
dc.contributor.authorMichalski, Jeff M.
dc.contributor.authorPalta, Jatinder R.
dc.contributor.authorSimon, Richard
dc.contributor.authorTen Haken, Randal K.
dc.contributor.authorTimmerman, Robert
dc.contributor.authorTunis, Sean
dc.contributor.authorColeman, C. Norman
dc.contributor.authorPurdy, James
dc.date2022-08-11T08:10:45.000
dc.date.accessioned2022-08-23T17:18:47Z
dc.date.available2022-08-23T17:18:47Z
dc.date.issued2012-07-01
dc.date.submitted2014-01-25
dc.identifier.citationInt J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):782-90. doi: 10.1016/j.ijrobp.2011.12.080. Epub 2012 Mar 15. <a href="http://dx.doi.org/10.1016/j.ijrobp.2011.12.080">Link to article on publisher's site</a>
dc.identifier.issn0360-3016 (Linking)
dc.identifier.doi10.1016/j.ijrobp.2011.12.080
dc.identifier.pmid22425219
dc.identifier.urihttp://hdl.handle.net/20.500.14038/47928
dc.description.abstractPURPOSE: 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.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=22425219&dopt=Abstract">Link to Article in PubMed</a>
dc.relation.urlhttp://dx.doi.org/10.1016/j.ijrobp.2011.12.080
dc.subjectClinical Trials as Topic
dc.subjectCredentialing
dc.subjectHumans
dc.subjectMulticenter Studies as Topic
dc.subjectNational Cancer Institute (U.S.)
dc.subjectNeoplasms
dc.subjectQuality Assurance, Health Care
dc.subjectQuality Improvement
dc.subjectQuality of Life
dc.subjectRadiotherapy Dosage
dc.subjectResearch Design
dc.subjectTechnology, Radiologic
dc.subjectUnited States
dc.subjectNeoplasms
dc.subjectOncology
dc.titleRedesigning 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
dc.typeJournal Article
dc.source.journaltitleInternational journal of radiation oncology, biology, physics
dc.source.volume83
dc.source.issue3
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/radiationoncology_pubs/31
dc.identifier.contextkey5020128
html.description.abstract<p>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.</p> <p>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.</p> <p>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.</p> <p>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.</p>
dc.identifier.submissionpathradiationoncology_pubs/31
dc.contributor.departmentQuality Assurance Review Center
dc.contributor.departmentDepartment of Radiation Oncology
dc.source.pages782-90


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