The role of medical physics experts in clinical trials: A guideline from the European Federation of Organisations for Medical Physics

• Published in: Physica medica Vol. 126; p. 104821
• Main Authors: Abbott, Natalie Louise, Chauvie, Stephane, Marcu, Loredana, DeJean, Catherine, Melidis, Christos, Wientjes, Rens, Gasnier, Anne, Lisbona, Albert, Luzzara, Marco, Mazzoni, Lorenzo Nicola, O’Doherty, Jim, Koutsouveli, Efi, Appelt, Ane, Hansen, Christian Rønn
• Format: Journal Article
• Language: English
• Published: Italy Elsevier Ltd 01-10-2024
• Subjects: Clinical trial; Education and training; Medical imaging; Radiation oncology; Radioprotection; Clinical trial; Medical imaging; Radiation oncology; Radioprotection; Education and training
• ISSN: 1120-1797; 1724-191X; 1724-191X
• DOI: 10.1016/j.ejmp.2024.104821

•Medical Physics Experts (MPEs) have a key role in clinical trials, they:•Should be involved in a trials design when it assesses new medical technology.•Should manage trial Quality Assurance, ensuring compliance to the protocol.•Must be involved with safety assessment & validation of clinical implementation.•Must handle the trial radiation safety and relevant regulatory aspects.
The EFOMP working group on the Role of Medical Physics Experts (MPEs) in Clinical Trials was established in 2010, with experts from across Europe and different areas of medical physics.
Their main aims were: (1) To develop a consensus guidance document for the work MPEs do in clinical trials across Europe. (2) Complement the work by American colleagues in AAPM TG 113 and guidance from National Member Organisations. (3) To cover external beam radiotherapy, brachytherapy, nuclear medicine, molecular radiotherapy, and imaging.
This document outlines the main output from this working group. Giving guidance to MPEs, and indeed all Medical Physicists (MP) and MP trainees wishing to work in clinical trials. It also gives guidance to the wider multidisciplinary team, advising where MPEs must legally be involved, as well as highlighting areas where MPEs skills and expertise can really add value to clinical trials.