Cancer registry as external control data for regulatory submission in Japan

Through the Clinical Innovation Network, Japan’s regulatory authorities have enhanced the development of registries that utilize real-world data (RWD). The Ministry of Health, Labour and Welfare has issued guidelines, whereas the Pharmaceuticals and Medical Devices Agency has conducted consultations...

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Главные авторы:	H. Bando, N. Okita, Y. Sakamoto, H. Sokuoka, Y. Nakamura, T. Hashimoto, T. Misumi, Y. Takeda, Y. Aoyagi, K. Mizuguchi, H.S. Okuma, N. Fuse, K. Yonemori, K. Nakamura, N. Yamamoto, T. Yoshino, A. Ohtsu
Формат:	Artigo
Язык:	Inglês
Опубликовано:	Elsevier 2024-12-01
Серии:	ESMO Real World Data and Digital Oncology
Предметы:	external control data new drug application real-world data real-world evidence data relevancy data reliability
Online-ссылка:	http://www.sciencedirect.com/science/article/pii/S294982012400050X
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