ESTRO 2023

Session Item

Saturday

May 13

08:45 - 10:00

Strauss 1

ESTRO-EFOMP: International/European initiatives in medical physics

Chair: Ben Heijmen, The Netherlands;

Chair: , Denmark

Session Type: Joint Symposium

Track: Physics

Journey:

08:45 - 09:03

EFOMP clinical trials update

Speaker: Natalie L. Abbott, United Kingdom

Presentation Number: SP-0029

Abstract

Abstract Title:

The role of medical physicists in clinical trials across Europe

Authors:

Natalie L. Abbott¹, Ane Appelt², Stephane Chauvie³, Catherine DeJean⁴, Anne Gasnier⁵, Efi Koutsouveli⁶, Albert Lisbona⁷, Marco Luzzara⁸, Loredana Marcu⁹, Christos Melidis¹⁰, Lorenzo Nicola Mazzoni¹¹, Jim O' Doherty¹², Rens Wientje¹³, Christian Rønn Hansen¹⁴

¹National RTTQA Group, Velindre Cancer Center, Radiotherapy Physics Department., Cardiff, United Kingdom; ²Leeds Institute of Medical Research at St James’s, University of Leeds;, Department of Medical Physics and Engineering, Leeds Cancer Centre, St. James’ University Hospital., Leeds, United Kingdom; ³Santa Croce e Carle Hospital, Department of Medical Physics, Cuneo, Italy; ⁴ Centre Antoine-Lacassagne, ., Nice, France; ⁵Centre Henri Becquerel, Radiotherapy Department, Rouen, United Kingdom; ⁶Hygeia Hospital, Department of Medical Physics, Athens, Greece; ⁷Institut de Cancérologie de l'Ouest, Bd J.Monod, ., Saint Herblain, France; ⁸Elekta AB, Stockholm.;, Elekta Medical Affairs global team, ., Italy; ⁹Faculty of Informatics & Science, University of Oradea;, Cancer Research Institute, University of South Australia, Adelaide, Oradea, Romania; ¹⁰CAP Santé, Clinique Maymard;, milliVolt.eu., Bastia, France; ¹¹Azienda USL Toscana Centro, SOC Fisica Sanitaria, ., Pistoia-Prato, Italy; ¹²Siemens Medical Solutions, Malvern PA, USA; Department of Radiology and Radiological Sciences, Medical University of South Carolina, Charleston SC, USA;, Radiography & Diagnostic Imaging, University College Dublin, Dublin, Ireland., ., USA; ¹³University Medical Centre, ., Utrecht, The Netherlands; ¹⁴Laboratory of Radiation Physics, Odense University Hospital; Institute of Clinical Research, University of Southern Denmark;, Danish Centre for Particle Therapy, Aarhus University Hospital, Denmark, Odense, Denmark

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Purpose or Objective

Medical physicists (MPs) (& experts, MPEs) play a key role in clinical trials that involve imaging or medical radioactive exposures.

The European Federation of Organisations for Medical Physics Working Group for “The Role of Medical Physicists in Clinical Trials” (WG) aims to create guidelines towards the standardisation of MP roles within clinical trials.

Material and Methods

The WG group has 19 members from 12 countries in Europe across all medical physics specialisms. Work started in 09/2019, final guidelines are expected by 09/2023.

To identify differences in trial involvement and to understand where guidance would be most useful, the WG produced a questionnaire targeting all EFOMP National Member Organisations (NMOs) across Europe.

The questionnaire included 20 quantitative and qualitative questions developed to cover the breadth of MP roles and practices, including everything in the trial process from setup to recruitment to clinical implementation of results.

Results

Of the 36 NMOs, 31(86.1%) responded to the questionnaire. The response rate improved our confidence that this is a topic of interest across Europe and indicated that a range of opinions and experiences were gathered.

MP involvement in clinical trials was found to vary greatly across Europe, with clear differences across the possible trial roles. Differences were also seen in the training and support available for staff working in clinical trials. Training is only available in 14 countries (45.2%), with only 1 NMO responding it is specific to MPs. This indicates a need for more guidance.

Following the data gathered from the questionnaire, the WG will produce guidelines to aid NMOs and individual centres in expanding the roles of MPs in clinical trials. The document will be structured to include the following areas: trial design, protocol writing and trial leadership roles; trial setup, credentialing, pre- and on-trial QA; imaging; data collection, management and analysis; clinical implementation; legal and regulatory responsibilities. Each section will highlight where MPs should be involved (e.g. from a legislative point of view), give guidance for training, and showcase where MP expertise can add value. It will be comprehensive to guide the multi-isciplinary team on MP roles and offer support for MPs to be more involved in clinical trials and associated research. Complementary EFOMP school editions and educational events will also be held.

Conclusion

The questionnaire response rate improved our confidence that this is a topic of interest across Europe and indicated that a range of opinions and experiences were gathered. This has informed the work of the WG, particularly as to what will be most useful in the final guidance document.

References

Loredana G. Marcu, Natalie L. Abbott, et. Al. The role of medical physicists in clinical trials across Europe, Physica Medica 2022; 100: 31-38.

Moran, J.M., et al., Guidance for the Physics Aspects of Clinical Trials: The Report of AAPM Task Group 113. 2018: Alexandria, Virginia, USA.