Recommendations for radiotherapy quality assurance in clinical trials

Camilla Panduro Nielsen; Eva Samsøe; Birgitte Vrou Offersen; Ebbe Laugaard Lorenzen; Gitte Persson; Hanna Rahbek Mortensen; Henrik Dahl Nissen; Ivan Richter Vogelius; Jesper Folsted Kallehauge; Ludvig Paul Muren; Mads Brincker; Mette van Overeem Felter; Rikke Hedegaard Dahlrot; Steffen Bjerre Hokland; Tine Schytte; Birgitte Mayland Havelund; Britta Weber; Ditte Sloth Møller; Eva Serup-Hansen; Kenneth Jensen; Kirsten Legård Jakobsen; Mirjana Josipovic; Simon Long Krogh; Slávka Lukacova; Lone Hoffmann; Christian Rønn Hansen

doi:10.1016/j.radonc.2025.110950

Recommendations for radiotherapy quality assurance in clinical trials

Camilla Panduro Nielsen, Eva Samsøe, Birgitte Vrou Offersen, Ebbe Laugaard Lorenzen, Gitte Persson, Hanna Rahbek Mortensen, Henrik Dahl Nissen, Ivan Richter Vogelius, Jesper Folsted Kallehauge, Ludvig Paul Muren, Mads Brincker, Mette van Overeem Felter, Rikke Hedegaard Dahlrot, Steffen Bjerre Hokland, Tine Schytte, Birgitte Mayland Havelund, Britta Weber, Ditte Sloth Møller, Eva Serup-Hansen, Kenneth JensenKirsten Legård Jakobsen, Mirjana Josipovic, Simon Long Krogh, Slávka Lukacova, Lone Hoffmann, Christian Rønn Hansen^*

^*Corresponding author af dette arbejde

Abstract

Robust quality assurance (QA) of clinical trials in radiotherapy (RT) is paramount for minimising uncertainties in treatment delivery, thereby strengthening the statistical power of the study and increasing the likelihood of accurately answering the research question. As RT techniques evolve and become more complex, establishing an appropriate QA program for a specific clinical trial becomes increasingly challenging, highlighting the importance of clear and standardised recommendations. This study provide such recommendations for Principal Investigators (PIs) to consider when planning and conducting RT Quality Assurance (RTQA) for clinical trials. They arise from experiences with RTQA in the clinical trials conducted in the Danish Multidisciplinary Cancer Groups (DMCGs). The recommendations include a checklist to guide PIs in developing an effective RTQA program.

Originalsprog	Engelsk
Artikelnummer	110950
Tidsskrift	Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology
Vol/bind	209
ISSN	0167-8140
DOI	https://doi.org/10.1016/j.radonc.2025.110950
Status	E-pub ahead of print - 22 maj 2025

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10.1016/j.radonc.2025.110950Licens: CC BY

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Nielsen, C. P., Samsøe, E., Offersen, B. V., Lorenzen, E. L., Persson, G., Mortensen, H. R., Nissen, H. D., Vogelius, I. R., Kallehauge, J. F., Muren, L. P., Brincker, M., Felter, M. V. O., Dahlrot, R. H., Hokland, S. B., Schytte, T., Havelund, B. M., Weber, B., Møller, D. S., Serup-Hansen, E., ... Hansen, C. R. (2025). Recommendations for radiotherapy quality assurance in clinical trials. Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, 209, Artikel 110950. Advance online publication. https://doi.org/10.1016/j.radonc.2025.110950

Nielsen, CP, Samsøe, E, Offersen, BV, Lorenzen, EL, Persson, G, Mortensen, HR, Nissen, HD, Vogelius, IR, Kallehauge, JF, Muren, LP, Brincker, M, Felter, MVO, Dahlrot, RH, Hokland, SB, Schytte, T, Havelund, BM, Weber, B, Møller, DS, Serup-Hansen, E, Jensen, K, Jakobsen, KL, Josipovic, M, Krogh, SL, Lukacova, S, Hoffmann, L & Hansen, CR 2025, 'Recommendations for radiotherapy quality assurance in clinical trials', Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, bind 209, 110950. https://doi.org/10.1016/j.radonc.2025.110950

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title = "Recommendations for radiotherapy quality assurance in clinical trials",

abstract = "Robust quality assurance (QA) of clinical trials in radiotherapy (RT) is paramount for minimising uncertainties in treatment delivery, thereby strengthening the statistical power of the study and increasing the likelihood of accurately answering the research question. As RT techniques evolve and become more complex, establishing an appropriate QA program for a specific clinical trial becomes increasingly challenging, highlighting the importance of clear and standardised recommendations. This study provide such recommendations for Principal Investigators (PIs) to consider when planning and conducting RT Quality Assurance (RTQA) for clinical trials. They arise from experiences with RTQA in the clinical trials conducted in the Danish Multidisciplinary Cancer Groups (DMCGs). The recommendations include a checklist to guide PIs in developing an effective RTQA program.",

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doi = "10.1016/j.radonc.2025.110950",

language = "English",

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AU - Nielsen, Camilla Panduro

AU - Samsøe, Eva

AU - Offersen, Birgitte Vrou

AU - Lorenzen, Ebbe Laugaard

AU - Persson, Gitte

AU - Mortensen, Hanna Rahbek

AU - Nissen, Henrik Dahl

AU - Vogelius, Ivan Richter

AU - Kallehauge, Jesper Folsted

AU - Muren, Ludvig Paul

AU - Brincker, Mads

AU - Felter, Mette van Overeem

AU - Dahlrot, Rikke Hedegaard

AU - Hokland, Steffen Bjerre

AU - Schytte, Tine

AU - Havelund, Birgitte Mayland

AU - Weber, Britta

AU - Møller, Ditte Sloth

AU - Serup-Hansen, Eva

AU - Jensen, Kenneth

AU - Jakobsen, Kirsten Legård

AU - Josipovic, Mirjana

AU - Krogh, Simon Long

AU - Lukacova, Slávka

AU - Hoffmann, Lone

AU - Hansen, Christian Rønn

PY - 2025/5/22

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N2 - Robust quality assurance (QA) of clinical trials in radiotherapy (RT) is paramount for minimising uncertainties in treatment delivery, thereby strengthening the statistical power of the study and increasing the likelihood of accurately answering the research question. As RT techniques evolve and become more complex, establishing an appropriate QA program for a specific clinical trial becomes increasingly challenging, highlighting the importance of clear and standardised recommendations. This study provide such recommendations for Principal Investigators (PIs) to consider when planning and conducting RT Quality Assurance (RTQA) for clinical trials. They arise from experiences with RTQA in the clinical trials conducted in the Danish Multidisciplinary Cancer Groups (DMCGs). The recommendations include a checklist to guide PIs in developing an effective RTQA program.

AB - Robust quality assurance (QA) of clinical trials in radiotherapy (RT) is paramount for minimising uncertainties in treatment delivery, thereby strengthening the statistical power of the study and increasing the likelihood of accurately answering the research question. As RT techniques evolve and become more complex, establishing an appropriate QA program for a specific clinical trial becomes increasingly challenging, highlighting the importance of clear and standardised recommendations. This study provide such recommendations for Principal Investigators (PIs) to consider when planning and conducting RT Quality Assurance (RTQA) for clinical trials. They arise from experiences with RTQA in the clinical trials conducted in the Danish Multidisciplinary Cancer Groups (DMCGs). The recommendations include a checklist to guide PIs in developing an effective RTQA program.

KW - Clinical trials

KW - Quality assurance

KW - Radiotherapy

KW - Recommendations

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U2 - 10.1016/j.radonc.2025.110950

DO - 10.1016/j.radonc.2025.110950

M3 - Review

C2 - 40412533

SN - 0167-8140

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JO - Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology

JF - Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology

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ER -

Recommendations for radiotherapy quality assurance in clinical trials

Abstract

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