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

• Published in: International journal of radiation oncology, biology, physics Vol. 83; no. 3; pp. 782 - 790
• Main Authors: Bekelman, Justin E., M.D, Deye, James A., Ph.D, Vikram, Bhadrasain, M.D, Bentzen, Soren M., Ph.D, Bruner, Deborah, Ph.D, Curran, Walter J., M.D, Dignam, James, Ph.D, Efstathiou, Jason A., M.D., D.Phil, FitzGerald, T.J., M.D, Hurkmans, Coen, Ph.D, Ibbott, Geoffrey S., Ph.D, Lee, J. Jack, Ph.D, Merchant, Thomas E., M.D, Michalski, Jeff, M.D, Palta, Jatinder R., Ph.D, Simon, Richard, D.Sc, Ten Haken, Randal K., Ph.D, Timmerman, Robert, M.D, Tunis, Sean, M.D, Coleman, C. Norman, M.D, Purdy, James, Ph.D
• Format: Journal Article Conference Proceeding
• Language: English
• Published: New York, NY Elsevier Inc 01.07.2012; Elsevier
• Subjects: Biological and medical sciences; BIOLOGICAL MARKERS; Clinical trial design; CLINICAL TRIALS; Clinical Trials as Topic - standards; Credentialing; General aspects; Hematology, Oncology and Palliative Medicine; Humans; Medical sciences; METRICS; Miscellaneous; Multicenter Studies as Topic - standards; National Cancer Institute (U.S.); NEOPLASMS; Neoplasms - radiotherapy; OPTIMIZATION; PROTON BEAMS; Public health. Hygiene; Public health. Hygiene-occupational medicine; QUALITY ASSURANCE; Quality Assurance, Health Care - organization & administration; Quality Assurance, Health Care - standards; Quality Improvement - standards; Quality insurance (general aspects); Quality of Life; Radiology; RADIOLOGY AND NUCLEAR MEDICINE; RADIOTHERAPY; Radiotherapy Dosage - standards; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Research Design - standards; Technology, Radiologic - standards; TOXICITY; United States; United States; Credentialing; Quality assurance; Clinical trial design; Radiotherapy; Human; Cancerology; Treatment; Evidence-based practice; Clinical trial; Evidence-based medicine; Recommendation; Public health
• ISSN: 0360-3016; 1879-355X
• DOI: 10.1016/j.ijrobp.2011.12.080

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.