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dc.contributor.authorVerkooijen, HMen_US
dc.contributor.authorKerkmeijer, LGWen_US
dc.contributor.authorFuller, CDen_US
dc.contributor.authorHuddart, Ren_US
dc.contributor.authorFaivre-Finn, Cen_US
dc.contributor.authorVerheij, Men_US
dc.contributor.authorMook, Sen_US
dc.contributor.authorSahgal, Aen_US
dc.contributor.authorHall, Een_US
dc.contributor.authorSchultz, Cen_US
dc.identifier.citationFrontiers in oncology, 2017, 7 pp. 59 - ?en_US
dc.description.abstractThe pace of innovation in radiation oncology is high and the window of opportunity for evaluation narrow. Financial incentives, industry pressure, and patients' demand for high-tech treatments have led to widespread implementation of innovations before, or even without, robust evidence of improved outcomes has been generated. The standard phase I-IV framework for drug evaluation is not the most efficient and desirable framework for assessment of technological innovations. In order to provide a standard assessment methodology for clinical evaluation of innovations in radiotherapy, we adapted the surgical IDEAL framework to fit the radiation oncology setting. Like surgery, clinical evaluation of innovations in radiation oncology is complicated by continuous technical development, team and operator dependence, and differences in quality control. Contrary to surgery, radiotherapy innovations may be used in various ways, e.g., at different tumor sites and with different aims, such as radiation volume reduction and dose escalation. Also, the effect of radiation treatment can be modeled, allowing better prediction of potential benefits and improved patient selection. Key distinctive features of R-IDEAL include the important role of predicate and modeling studies (Stage 0), randomization at an early stage in the development of the technology, and long-term follow-up for late toxicity. We implemented R-IDEAL for clinical evaluation of a recent innovation in radiation oncology, the MRI-guided linear accelerator (MR-Linac). MR-Linac combines a radiotherapy linear accelerator with a 1.5-T MRI, aiming for improved targeting, dose escalation, and margin reduction, and is expected to increase the use of hypofractionation, improve tumor control, leading to higher cure rates and less toxicity. An international consortium, with participants from seven large cancer institutes from Europe and North America, has adopted the R-IDEAL framework to work toward coordinated, evidence-based introduction of the MR-Linac. R-IDEAL holds the promise for timely, evidence-based introduction of radiotherapy innovations with proven superior effectiveness, while preventing unnecessary exposure of patients to potentially harmful interventions.en_US
dc.format.extent59 - ?en_US
dc.titleR-IDEAL: A Framework for Systematic Clinical Evaluation of Technical Innovations in Radiation Oncology.en_US
dc.typeJournal Article
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfFrontiers in oncologyen_US
pubs.notesNo embargoen_US
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/ICR-CTSU Urology and Head and Neck Trials Team
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Clinical Academic Radiotherapy (Huddart)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.embargo.termsNo embargoen_US
icr.researchteamICR-CTSU Urology and Head and Neck Trials Teamen_US
icr.researchteamClinical Academic Radiotherapy (Huddart)en_US
dc.contributor.icrauthorHall, Emmaen_US
dc.contributor.icrauthorHuddart, Roberten_US

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