title: 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.
abstract: OBJECTIVE
  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
  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.
  
  
  CONCLUSIONS
  Radiotherapy QA can affect clinical trial accrual, cost, outcomes, and generalizability. To achieve maximum benefit, QA programs must become more efficient and evidence-based.
authors.affiliation: University of Pennsylvania, Philadelphia, PA 19104, USA. bekelman@uphs.upenn.edu
authors.forename: Justin E
authors.initials: JE
authors.lastname: Bekelman
authors.forename: James A
authors.initials: JA
authors.lastname: Deye
authors.forename: Bhadrasain
authors.initials: B
authors.lastname: Vikram
authors.forename: Soren M
authors.initials: SM
authors.lastname: Bentzen
authors.forename: Deborah
authors.initials: D
authors.lastname: Bruner
authors.forename: Walter J
authors.initials: WJ
authors.lastname: Curran
authors.forename: James
authors.initials: J
authors.lastname: Dignam
authors.forename: Jason A
authors.initials: JA
authors.lastname: Efstathiou
authors.forename: T J
authors.initials: TJ
authors.lastname: FitzGerald
authors.forename: Coen
authors.initials: C
authors.lastname: Hurkmans
authors.forename: Geoffrey S
authors.initials: GS
authors.lastname: Ibbott
authors.forename: J Jack
authors.initials: JJ
authors.lastname: Lee
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Merchant
authors.forename: Jeff
authors.initials: J
authors.lastname: Michalski
authors.forename: Jatinder R
authors.initials: JR
authors.lastname: Palta
authors.forename: Richard
authors.initials: R
authors.lastname: Simon
authors.forename: Randal K
authors.initials: RK
authors.lastname: Ten Haken
authors.forename: Robert
authors.initials: R
authors.lastname: Timmerman
authors.forename: Sean
authors.initials: S
authors.lastname: Tunis
authors.forename: C Norman
authors.initials: CN
authors.lastname: Coleman
authors.forename: James
authors.initials: J
authors.lastname: Purdy
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D003406:Credentialing; D006801:Humans; D015337:Multicenter Studies as Topic / Q000592:standards; D054547:National Cancer Institute (U.S.); D009369:Neoplasms / Q000532:radiotherapy*; D011785:Quality Assurance, Health Care / Q000458:organization & administration / Q000592:standards*; D058996:Quality Improvement / Q000592:standards*; D011788:Quality of Life; D011879:Radiotherapy Dosage / Q000592:standards; D012107:Research Design / Q000592:standards*; D013679:Technology, Radiologic / Q000592:standards; D014481:United States