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. 2010 Dec;2(4):245-52.
doi: 10.3978/j.issn.2072-1439.2010.11.10.

Medical imaging in new drug clinical development

Yi-Xiang Wang  1 , Min Deng
Affiliations

Medical imaging in new drug clinical development

Yi-Xiang Wang et al. J Thorac Dis. 2010 Dec.

Abstract

Medical imaging can help answer key questions that arise during the drug development process. The role of medical imaging in new drug clinical trials includes identification of likely responders; detection and diagnosis of lesions and evaluation of their severity; and therapy monitoring and follow-up. Nuclear imaging techniques such as PET can be used to monitor drug pharmacokinetics and distribution and study specific molecular endpoints. In assessing drug efficacy, imaging biomarkers and imaging surrogate endpoints can be more objective and faster to measure than clinical outcomes, and allow small group sizes, quick results and good statistical power. Imaging also has important role in drug safety monitoring, particularly when there is no other suitable biomarkers available. Despite the long history of radiological sciences, its application to the drug development process is relatively recent. This review highlights the processes, opportunities, and challenges of medical imaging in new drug development.

Keywords: clinical development; clinical trials; diagnostic radiology; medical imaging; new drug; pharmaceutical industry.

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Conflict of interest statement

No potential conflict of interest.

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