Toward widespread use of virtual trials in medical imaging innovation and regulatory science.

Autor: Abadi E; Center for Virtual Imaging Trials, Carl E. Ravin Advanced Imaging Laboratories, Departments of Radiology and Electrical & Computer Engineering, Medical Physics Graduate Program, Duke University, Durham, North Carolina, USA., Barufaldi B; Department of Radiology, University of Pennsylvania, Philadelphia, Pennsylvania, USA., Lago M; Division of Imaging, Diagnostics and Software Reliability, OSEL, CDRH, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Badal A; Division of Imaging, Diagnostics and Software Reliability, OSEL, CDRH, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Mello-Thoms C; Department of Radiology, University of Iowa, Iowa City, Iowa, USA., Bottenus N; Department of Mechanical Engineering, University of Colorado Boulder, Boulder, Colorado, USA., Wangerin KA; Research and Development, Pharmaceutical Diagnostics, GE HealthCare, Marlborough, Massachusetts, USA., Goldburgh M; NTT DATA Industry Solutions, Plano, Texas, USA., Tarbox L; Department of Biomedical Informatics, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA., Beaucage-Gauvreau E; Institute of Physics-based Modeling for in silico Health (iSi Health), KU Leuven, Leuven, Belgium., Frangi AF; Christabel Pankhurst Institute, Division of Informatics, Imaging and Data Sciences, Department of Computer Science, University of Manchester, Manchester, UK.; Alan Turing Institute, British Library, London, UK., Maidment A; Department of Radiology, University of Pennsylvania, Philadelphia, Pennsylvania, USA., Kinahan PE; Departments of Radiology, Bioengineering, and Physics, University of Washington, Seattle, Washington, USA., Bosmans H; Departments of Radiology and Medical Radiation Physics, KU Leuven, Leuven, Belgium., Samei E; Center for Virtual Imaging Trials, Carl E. Ravin Advanced Imaging Laboratories, Departments of Radiology and Electrical & Computer Engineering, Medical Physics Graduate Program, Duke University, Durham, North Carolina, USA.
Jazyk: angličtina
Zdroj: Medical physics [Med Phys] 2024 Oct 06. Date of Electronic Publication: 2024 Oct 06.
DOI: 10.1002/mp.17442
Abstrakt: The rapid advancement in the field of medical imaging presents a challenge in keeping up to date with the necessary objective evaluations and optimizations for safe and effective use in clinical settings. These evaluations are traditionally done using clinical imaging trials, which while effective, pose several limitations including high costs, ethical considerations for repetitive experiments, time constraints, and lack of ground truth. To tackle these issues, virtual trials (aka in silico trials) have emerged as a promising alternative, using computational models of human subjects and imaging devices, and observer models/analysis to carry out experiments. To facilitate the widespread use of virtual trials within the medical imaging research community, a major need is to establish a common consensus framework that all can use. Based on the ongoing efforts of an AAPM Task Group (TG387), this article provides a comprehensive overview of the requirements for establishing virtual imaging trial frameworks, paving the way toward their widespread use within the medical imaging research community. These requirements include credibility, reproducibility, and accessibility. Credibility assessment involves verification, validation, uncertainty quantification, and sensitivity analysis, ensuring the accuracy and realism of computational models. A proper credibility assessment requires a clear context of use and the questions that the study is intended to objectively answer. For reproducibility and accessibility, this article highlights the need for detailed documentation, user-friendly software packages, and standard input/output formats. Challenges in data and software sharing, including proprietary data and inconsistent file formats, are discussed. Recommended solutions to enhance accessibility include containerized environments and data-sharing hubs, along with following standards such as CDISC (Clinical Data Interchange Standards Consortium). By addressing challenges associated with credibility, reproducibility, and accessibility, virtual imaging trials can be positioned as a powerful and inclusive resource, advancing medical imaging innovation and regulatory science.
(© 2024 American Association of Physicists in Medicine.)
Databáze: MEDLINE
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