癌症登记处作为外部控制数据,用于在日本提交监管机构的数据
H Bando1,2,3, N Okita4, Y Sakamoto1
1Translational Research Support Office, Division of Drug and Diagnostic Development Promotion, Department for the Promotion of Drug and Diagnostic Development, National Cancer Center Hospital East, Kashiwa, Chiba.
ESMO real world data and digital oncology
|February 6, 2026
概括
日本 日本 日本 日本 日本.
科学领域:
- 监管科学 监管科学
- 现实世界数据 (RWD) 使用情况
- 瘤学注册表 瘤学注册表
背景情况:
- 日本的监管机构,通过临床创新网络,已经改进了真实世界数据 (RWD) 注册表的开发.
- 指导方针和商提高了RWD注册表的完整性和有效使用.
- 癌症注册表越来越多地被用作监管和学术环境中的外部控制组.
研究的目的:
- 审查日本监管机构关于癌症登记的观点和指导方针.
- 为解决由于标准不清楚而导致药物批准中RWD/现实世界证据 (RWE) 的有限采用问题.
- 为在日本更广泛地应用RWD/RWE制定新的指导方针提供信息.
主要方法:
- 对指导方针的审查和监管机构 (卫生,劳动和福利部,制药和医疗器械机构) 的商.
- 对已建立的癌症注册表进行分析 (例如,SCRUM-Japan注册表,MASTER KEY,GALAXY).
- 启动"REALISE研究",以确定药物批准的数据相关性和可靠性.
主要成果:
- 已经建立了几个高质量的癌症注册表,SCRUM-Japan获得了显著的监管批准.
- 监管机构和学术机构促进使用癌症注册数据作为外部控制.
- 关于RWD/RWE药物批准标准的不确定性阻碍了日本更广泛的监管使用.
结论:
- 需要更明确的标准来增加日本对RWD/RWE的监管使用.
- "REALISE研究"旨在定义数据要求和方法,以确保可靠性.
- 调查结果将指导制定指导方针草案,以扩大RWD/RWE在日本的应用.
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