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Ethics, Regulations, and Clinical Development of Precision Medicine: Activating with Molecular Imaging

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Personalized Pathway-Activated Systems Imaging in Oncology

Abstract

“Precision medicine” is becoming a keyword toward new and more effective healthcare in the twenty-first century, a concept evolved from “personalized medicine.” Therefore, it is a prerequisite for the community of molecular imaging to clarify elements of ethics, regulations, and clinical development strategies to achieve the goal of precision medicine, activated with imaging technologies. Through literature review and continuous discussion with people of related communities, we identified key elements from view of regulations and clinical development strategies as follows: (1) quality assurance and standardization of methodologies and procedures of imaging technologies and (2) formulation of larger-scale global clinical trial network and imaging archives, both of which would accelerate regulatory approval of new therapeutic drugs and diagnostic technologies. Additionally, key elements of ethics are as follows: (1) view of individual ethics to protect human rights and human dignity, i.e., (i) privacy protection, (ii) right to know and right not to know, as well as (iii) presymptomatic diagnosis consultation, and (2) view of collective ethics to assure social value such as (i) clinical trial registration and data sharing, (ii) justifiable commercialization, and (iii) preventing exploitation and stigmatization. In conclusion, precision medicine can be activated with molecular imaging, through more global collaborative initiatives, which recognize and have a profound understanding of the characteristics of science, regulations, and ethics in the era of precision medicine.

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Acknowledgment

This paper is based on our studies on PET drug-related regulations in the USA granted by the Japanese Ministry of Health, Labour and Welfare, titled “Regulatory frameworks of the United States and other countries concerning nuclear medicine diagnosis using PET drugs produced by an in-house PET drug synthesizer” in 2011 and 2012 fiscal year and another one titled “Regulatory science concerning clinical application of nuclear medicine diagnosis using PET drugs produced by an in-house PET drug synthesizer” in 2013 and 2014 fiscal year. The material discussed for this paper is based on a presentation by Chieko Kurihara: Ethics and regulation of precision medicine in nuclear medicine: Toward more international collaboration in the world. In: Precision Medicine Forum in Nuclear Medicine. Sept 26 to 27, 2015. Blue Horizon International Hotel, Linyi, Shan dong Province, China, invited by the organizer Professor Yaming Li, President of Chinese Society of Nuclear Medicine; Professor and Director, Department of Nuclear Medicine The first Hospital of China Medical University.

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Authors and Affiliations

  1. National Institute for Quantum and Radiological Science and Technology, Chiba, Japan

    Chieko Kurihara

  2. School of Medicine, Yokohama City University, Yokohama, Japan

    Tomio Inoue

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  1. Chieko Kurihara
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  2. Tomio Inoue
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Correspondence to Chieko Kurihara .

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Editors and Affiliations

  1. School of Medicine, Yokohama City University, Yokohama, Japan

    Tomio Inoue

  2. Vyripharm Biopharmaceuticals, University of Texas Health Science Center, Houston, Texas, USA

    David Yang

  3. Renji Hospital / Department of Nuclear Medicine, Shanghai Jiao Tong University, Shanghai, China

    Gang Huang

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Kurihara, C., Inoue, T. (2017). Ethics, Regulations, and Clinical Development of Precision Medicine: Activating with Molecular Imaging. In: Inoue, T., Yang, D., Huang, G. (eds) Personalized Pathway-Activated Systems Imaging in Oncology. Springer, Singapore. https://doi.org/10.1007/978-981-10-3349-0_6

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