DIA/JSMO Joint Symposium

[DJS1] DIA/JSMO Joint Symposium　Current status and perspective of oncological clinical development utilizing the external control
【E】

Sat. Feb 19, 2022 8:20 AM - 9:50 AM Room 10 (Royal Room, 1F, The Prince Kyoto Takaragaike)

Chair：Atsushi Ohtsu（Director, National Cancer Center Hospital East），Yoshiaki Uyama（Pharmaceuticals and Medical Devices Agency）

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[DJS-1] An Update from the US Food and Drug Administration on Real-world Data and Real-world Evidence

^○Gerald J. Dal Pan (US Food and Drug Administration)

[DJS-2] The Utilization of Real- World Data in Japan - Current Status and Future Plans

^○Kihito Takahashi (BONAC CORPORATION)

[DJS-3] Utilizing real-world data as an external control for new drug approval in molecular subtype: experience in SCRUM-Japan Registry

^○Hideaki Bando¹, Yoshiaki Nakamura¹, Yasutoshi Sakamoto¹, Hiromi Hasegawa¹, Atsushi Ohtsu² (1.Translational Research Support Section, National Cancer Center Hospital East, 2.National Cancer Center Hospital East)

[DJS-4] ARCAD-Asia Initiative: Leveraging Yesterday's Data for Tomorrow

^○Eiji Oki¹, Takayuki Yoshino^2,5, Kentaro Yamazaki³, Hideaki Bando^2,5, Yoshihiko Maehara⁴, Atushi Ohtsu⁶ (1.Department of Surgery and Science, Kyushu University, 2.Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, 3.Division of Gastrointestinal Oncology, Shizuoka Cancer Center, 4.Kyushu Central Hospital of Mutual Aid Association of Public School of Teachers, 5.Division of Data Science, National Cancer Center Hospital East, 6.National Cancer Center Hospital East)