Abstract
AbstractDuring the last two decades, imaging in drug development has been greatly advanced in a diversity of therapeutic fields, especially in the oncology field. As regulatory agencies seek robust evidence for primary endpoints, as much as possible, medical imaging usage is rapidly increased to support the primary endpoints in clinical trials. The addition of medical imaging in the clinical trials requires logistical and technical considerations, as follows: (1) selection of appropriate qualified imaging biomarker, (2) standardization of imaging acquisition, archive, and analysis, (3) independent blinded image review, and (4) system for complex workflow and regulatory compliance. In 2018, US FDA issued “Clinical Trial Imaging Endpoint Process Standards Guidance for Industry” so that pharmaceutical companies, imaging scientists, and clinical trial professionals can utilize imaging in a clinical trial as an appropriate manner. In addition, preclinical imaging usage has been also increased in drug development, and recently incorporated in the clinical trial process, so-called co-clinical trial. The co-clinical trials, hence, enable bidirectional translation research between bench and bedside. Therefore, imaging professionals should be aware of these global trends in imaging for drug development.
Published Version
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