Abstract
Most of the international clinical trials in Japan have been sponsored by pharmaceutical companies. There are only a few academic international trials, and if any, most were led by Western countries. Since 2018, National Cancer Center Hospital (NCCH) has been conducting Japan-led investigator-initiated clinical trials aimed at obtaining regulatory approval for off-label drugs with the participation of South Korea, Taiwan, and Singapore (PATHWAY trial). Since 2020, we have launched the ATLAS project with a support from AMED to provide infrastructure and capacity building programs and education and to conduct international clinical trials involving not only the existing collaborators but also some ASEAN countries, Thailand, Malaysia, Vietnam, Philippines, and Indonesia.
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