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 for this work

6 Citations (Scopus)

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.

Original language	English
Article number	110950
Journal	Radiotherapy and Oncology
Volume	209
Number of pages	11
ISSN	0167-8140
DOIs	https://doi.org/10.1016/j.radonc.2025.110950
Publication status	Published - Aug 2025

Keywords

Clinical trials
Quality assurance
Radiotherapy
Recommendations
Quality Assurance, Health Care/standards
Neoplasms/radiotherapy
Humans
Radiotherapy/standards
Denmark
Clinical Trials as Topic/standards

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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, 209, Article 110950. 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, vol. 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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author = "Nielsen, \{Camilla Panduro\} and Eva Sams{\o}e and Offersen, \{Birgitte Vrou\} and Lorenzen, \{Ebbe Laugaard\} and Gitte Persson and Mortensen, \{Hanna Rahbek\} and Nissen, \{Henrik Dahl\} and Vogelius, \{Ivan Richter\} and Kallehauge, \{Jesper Folsted\} and Muren, \{Ludvig Paul\} and Mads Brincker and Felter, \{Mette van Overeem\} and Dahlrot, \{Rikke Hedegaard\} and Hokland, \{Steffen Bjerre\} and Tine Schytte and Havelund, \{Birgitte Mayland\} and Britta Weber and M{\o}ller, \{Ditte Sloth\} and Eva Serup-Hansen and Kenneth Jensen and Jakobsen, \{Kirsten Leg{\aa}rd\} and Mirjana Josipovic and Krogh, \{Simon Long\} and Sl{\'a}vka Lukacova and Lone Hoffmann and Hansen, \{Christian R{\o}nn\}",

year = "2025",

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

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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

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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.

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KW - Quality assurance

KW - Radiotherapy

KW - Recommendations

KW - Quality Assurance, Health Care/standards

KW - Neoplasms/radiotherapy

KW - Humans

KW - Radiotherapy/standards

KW - Denmark

KW - Clinical Trials as Topic/standards

UR - https://www.scopus.com/pages/publications/105007293153

U2 - 10.1016/j.radonc.2025.110950

DO - 10.1016/j.radonc.2025.110950

M3 - Review

C2 - 40412533

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VL - 209

JO - Radiotherapy and Oncology

JF - Radiotherapy and Oncology

M1 - 110950

ER -

Recommendations for radiotherapy quality assurance in clinical trials

Abstract

Keywords

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