Yuji Uehara, Medical Oncologist, National Cancer Center, Japan, posted the following on X:
“Cancer registry (RWD) as external control data for regulatory submission in Japan:
- SCRUM-Japan: First regulatory approval for HER2+ colorectal cancer.
- MASTER KEY: Platform for rare cancers with 12 pharma partners.
- GALAXY: Large-scale DNA monitoring registry.
- REALISE: New initiative to standardize data quality (ARCAD global DB, SCRUM-Japan, and Flatiron Health RWD).”
Cancer registry as external control data for regulatory submission in Japan
Authors: 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