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Annual Report 2021

Department of Clinical Research Support

Hideaki Bando, Yoshiaki Nakamura, Takao Fujisawa, Masayuki Hata, Ryuta Mitani, Izumi Miki, Naomi Kuramoto, Yasutoshi Sakamoto, Hiroko Ichiki, Satoshi Horasawa, Hiroki Sokuoka, Hiroshi Uchigata, Kana Kitajima, Mihoko Yuasa, Yui Ogata, Sunao Fujioka, Natsuko Honda, Machiko Kumagami

The Team and What We Do

Translational Research Support Section

 Mainly supports the secretariat and data center operations for multicenter clinical research.

Research activities

Translational Research Support Section:

 Supports a total of 40 clinical research projects. In terms of large-scale multicenter studies, 230 patients with solid or hematological malignancies were enrolled in MONSTAR-SCREEN-2, 640 patients in MONSTAR-SCREEN, 1082 patients in GOZILA, 2473 patients in CIRCULATE-Japan, 750 patients in COSMOS, and 182 patients in HM-SCREEN. Nine papers and 28 conference reports were presented, including a study published in Nature Medicine that showed the efficacy of dual-HER2 targeted therapy for patients with HER2-positive colorectal cancer. In addition, four new drugs and six diagnostics were approved using the SCRUM-Japan platform.

Education

Translational Research Support Section

 Ten staff members were certified as genome medical research coordinators and 1 staff member was certified as a Certified Research Coordinator (CRC) in FY2021. In terms of retention management, we encouraged staff to join academic societies and acquire qualifications as part of our education and training to improve their skills and prepare them for new projects.

Future prospects

Translational Research Support Section

1) SCRUM-Asia was established as an overseas development of SCRUM-Japan. Cases are planned to be enrolled from Taiwan, Thailand, and Malaysia in the summer of 2022, and Vietnam, Singapore, and Malaysia will join in the winter of 2022. For the following fiscal year and beyond, expansion to Australia, Indonesia, and other countries is under consideration.

2) MONSTAR-SCREEN-2, which is based on multi-omics data such as DNA/RNA analysis of tissue and blood, immunomultiplex staining, etc., was launched on May 25, 2021, and 230 cases were registered in FY2021. We are scheduled to start a cross-organ cohort in FY2022, and also to start sharing an integrated database that stores multi-omics data.