R-IDEAL: a framework for systematic clinical evaluation of technical innovations in radiation oncology.
AffiliationImaging Division, University Medical Center Utrecht, Utrecht, Netherlands
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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.
CitationR-IDEAL: a framework for systematic clinical evaluation of technical innovations in radiation oncology. 2017, 7:59 Front Oncol
JournalFrontiers in Oncology
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- Authors: Kerkmeijer LG, Fuller CD, Verkooijen HM, Verheij M, Choudhury A, Harrington KJ, Schultz C, Sahgal A, Frank SJ, Goldwein J, Brown KJ, Minsky BD, van Vulpen M, MR-Linac Consortium Clinical Steering Committee.
- Issue date: 2016
- The MOMENTUM Study: An International Registry for the Evidence-Based Introduction of MR-Guided Adaptive Therapy.
- Authors: de Mol van Otterloo SR, Christodouleas JP, Blezer ELA, Akhiat H, Brown K, Choudhury A, Eggert D, Erickson BA, Faivre-Finn C, Fuller CD, Goldwein J, Hafeez S, Hall E, Harrington KJ, van der Heide UA, Huddart RA, Intven MPW, Kirby AM, Lalondrelle S, McCann C, Minsky BD, Mook S, Nowee ME, Oelfke U, Orrling K, Sahgal A, Sarmiento JG, Schultz CJ, Tersteeg RJHA, Tijssen RHN, Tree AC, van Triest B, Hall WA, Verkooijen HM
- Issue date: 2020
- Regarding: Rosenthal DI, Glatstein E. "We've Got a Treatment, but What's the Disease?" The Oncologist 1996;1.
- Authors: Lunsford LD, Flickinger JC, Larson D
- Issue date: 1997
- [Proton therapy and the importance of RCT].
- Authors: Verkooijen HM
- Issue date: 2021 Jul 22
- First 500 Fractions Delivered with a Magnetic Resonance-guided Radiotherapy System: Initial Experience.
- Authors: Sahin B, Zoto Mustafayev T, Gungor G, Aydin G, Yapici B, Atalar B, Ozyar E
- Issue date: 2019 Dec 24