Challenges to the management of oncologic theranostics clinical trials: recommendations for the conduct of theranostics trials at investigational sites.
IF 2.3 Q3 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING
Nicholas P Gruszauskas, Joseph Steiner, Krista Dillingham
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引用次数: 0
Abstract
Purpose: Advancements in radionuclide imaging and therapy techniques have created a groundswell of enthusiasm in the recently designated field of theranostics. This has increased the need for facilities that are able to participate in clinical trials for investigational theranostic agents. Theranostics clinical trials present several unique challenges that will tax the resources and staff of most medical centers. Our purpose is to describe the unique logistical and administrative challenges associated with theranostics clinical trials, propose strategies for addressing them, and make recommendations regarding trial conduct to the community at large.
Approach: The authors' experiences reviewing, implementing, and managing theranostics trials at their institution were used to identify common activities and challenges.
Results: Several key categories of requirements and challenges were identified. Multidisciplinary teams consisting of nuclear medicine, oncology, nursing, clinical research, and administrative staff are necessary to adequately perform all trial-related activities. Strategies are proposed to address these challenges and activities at the institutional and industry levels.
Conclusion: The unique challenges inherent to theranostics clinical trials require a focused investment of time, effort, and resources from all stakeholders. Institutions that wish to participate in these trials must develop the infrastructure necessary to fully support the breadth of activities they require. Implementation of the strategies and recommendations presented here will ensure the successful conduct of these trials and will improve efficiency across the community.
期刊介绍：
JMI covers fundamental and translational research, as well as applications, focused on medical imaging, which continue to yield physical and biomedical advancements in the early detection, diagnostics, and therapy of disease as well as in the understanding of normal. The scope of JMI includes: Imaging physics, Tomographic reconstruction algorithms (such as those in CT and MRI), Image processing and deep learning, Computer-aided diagnosis and quantitative image analysis, Visualization and modeling, Picture archiving and communications systems (PACS), Image perception and observer performance, Technology assessment, Ultrasonic imaging, Image-guided procedures, Digital pathology, Biomedical applications of biomedical imaging. JMI allows for the peer-reviewed communication and archiving of scientific developments, translational and clinical applications, reviews, and recommendations for the field.
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