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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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Hoofdauteurs: 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
Formaat: Artigo
Taal:Inglês
Gepubliceerd in: Elsevier 2024-12-01
Reeks:ESMO Real World Data and Digital Oncology
Onderwerpen:
external control data
new drug application
real-world data
real-world evidence
data relevancy
data reliability
Online toegang:http://www.sciencedirect.com/science/article/pii/S294982012400050X
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