Prioritizing clinical trial quality assurance for photons and protons: a failure modes and effects analysis (FMEA) comparison
Authors
Taylor, P. A.Hoffmann, L.
Kelly, S. M.
Kry, S. F.
Sloth Møller, D.
Miles, E.
Palmans, H.
Akbarov, K.
Aznar, Marianne Camille
Clementel, E.
Corning, C.
Effeney, R.
Healy, B.
Moore, A.
Nakamura, M.
Patel, S.
Shaw, M.
Stock, M.
Lehmann, J.
Clark, C. H.
Affiliation
Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USAIssue Date
2023
Metadata
Show full item recordAbstract
Background and purpose: The Global Clinical Trials RTQA Harmonization Group (GHG) set out to evaluate and prioritize clinical trial quality assurance. Methods: The GHG compiled a list of radiotherapy quality assurance (QA) tests performed for proton and photon therapy clinical trials. These tests were compared between modalities to assess whether there was a need for different types of assessments per modality. A failure modes and effects analysis (FMEA) was performed to assess the risk of each QA failure. Results: The risk analysis showed that proton and photon therapy shared four out of five of their highest-risk failures (end-to-end anthropomorphic phantom test, phantom tests using respiratory motion, pre-treatment patient plan review of contouring/outlining, and on-treatment/post-treatment patient plan review of dosimetric coverage). While similar trends were observed, proton therapy had higher risk failures, driven by higher severity scores. A sub-analysis of occurrence × severity scores identified high-risk scores to prioritize for improvements in RTQA detectability. A novel severity scaler was introduced to account for the number of patients affected by each failure. This scaler did not substantially alter the ranking of tests, but it elevated the QA program evaluation to the top 20th percentile. This is the first FMEA performed for clinical trial quality assurance. Conclusion: The identification of high-risk errors associated with clinical trials is valuable to prioritize and reduce errors in radiotherapy and improve the quality of trial data and outcomes, and can be applied to optimize clinical radiotherapy QA.Citation
Taylor PA, Hoffmann L, Kelly SM, Kry SF, Sloth Møller D, Miles E, et al. Prioritizing Clinical Trial Quality Assurance for Photons and Protons: A Failure Modes and Effects Analysis (FMEA) Comparison. Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology. 2023 Jan 25:109494. PubMed PMID: 36708923. Epub 2023/01/29. eng.Journal
Radiotherapy and OncologyDOI
10.1016/j.radonc.2023.109494PubMed ID
36708923Additional Links
https://dx.doi.org/10.1016/j.radonc.2023.109494Type
ArticleLanguage
enae974a485f413a2113503eed53cd6c53
10.1016/j.radonc.2023.109494
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