ESTRO 2023 - Abstract Book

S9

Saturday 13 May

ESTRO 2023

1 National RTTQA Group, Velindre Cancer Center, Radiotherapy Physics Department., Cardiff, United Kingdom; 2 Leeds 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; 3 Santa Croce e Carle Hospital, Department of Medical Physics, Cuneo, Italy; 4 Centre Antoine-Lacassagne, ., Nice, France; 5 Centre Henri Becquerel, Radiotherapy Department, Rouen, United Kingdom; 6 Hygeia Hospital, Department of Medical Physics, Athens, Greece; 7 Institut de Cancérologie de l'Ouest, Bd J.Monod, ., Saint Herblain, France; 8 Elekta AB, Stockholm.;, Elekta Medical Affairs global team, ., Italy; 9 Faculty of Informatics & Science, University of Oradea;, Cancer Research Institute, University of South Australia, Adelaide, Oradea, Romania; 10 CAP Santé, Clinique Maymard;, milliVolt.eu., Bastia, France; 11 Azienda USL Toscana Centro, SOC Fisica Sanitaria, ., Pistoia-Prato, Italy; 12 Siemens 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; 13 University Medical Centre, ., Utrecht, The Netherlands; 14 Laboratory 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 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. Materials 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. SP-0030 SAMIRA Study on the implementation of Council Directive 2013/59/Euratom requirements for medical equipment with respect to monitoring and control of patient’s radiation exposures A. Lopez Medina 1 , M. Nicolas 2 , D. Visvikis 3 , J. Andersson 4