Presentation Toward Asian Collaborative Clinical Trial Network

栗原, 千絵子

2016-11-04
Description
Background: International collaborative clinical trial network has been more and more facilitated aiming at global regulatory approval of new medical technologies. Especially in the era of “precision medicine”, more precise characterization and classification of therapeutic target population has become to be required. In such situation, PET (positron emission tomography) imaging technology plays key role from the stage of exploratory phase to approval process of new drug development. Hence, clinical trial network along with standardization and validation of PET drug manufacturing and PET imaging site are prerequisite for successful development.Many of Western global companies and academic institutes have developed clinical trial network utilizing PET imaging. In order to facilitate precision medicine utilizing PET imaging more in Asian regions and to expand it aiming at global health, it is necessary to develop Asian-oriented clinical trial network utilizing PET imaging, in ethical and regulatory compliant manner.Methods: Narrative, non-systematic review of literatures, based on experience of our international collaborations with Western and Asian PET communities.Results: Our findings on importance of facilitating Asian-initiated clinical trial network are: (1) to help more efficient participation in Western-initiated international clinical trials in terms of a) promoting standardization of imaging methodology/procedures and PET drug manufacturing; and b) considering characteristics of subgroups of Asian populations for “precision medicine”; (2) to contribute to development of medical technologies for diseases more prevalent in Asian region; (3) to contribute to expanding Asian academic-initiated innovation for global health.Conclusions: Asian-initiated clinical trial network using PET imaging is critically important for promoting “global health” and “precision medicine”, not only for Asian but also wider population in the world.
第56回日本核医学会学術総会 ARCCNM/ASNMシンポジウムでの講演

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