现实世界数据在日本瘤护理中的新兴作用
概括
日本的真实世界数据 (RWD) 对于加速癌症治疗批准和改善患者获取数据至关重要. 包括电子健康记录在内的瘤RWD正在开发,以提高癌症护理效率.
科学领域:
- 在瘤学瘤学.
- 现实世界数据 (RWD)
- 医疗信息学 医疗信息学
背景情况:
- 新型抗癌疗法的批准量急剧增加,但有效的治疗方法的有效患者获取仍然是一个挑战.
- 现实世界数据 (RWD) 在美国和欧洲越来越多地用于监管提交和解决未满足的患者需求.
- 在日本,由于高癌症发病率和特定的区域因素,瘤RWD特别重要.
研究的目的:
- 要突出在日本瘤RWD日益增长的重要性和发展.
- 展示在监管流程和数据策划工作中使用RWD的例子.
- 强调RWD在改善患者获得有效癌症治疗方面的潜力.
主要方法:
- 在监管批准中利用SCRUM-Japan注册表获取外部控制数据.
- 使用先进的数据处理从电子健康记录中编辑纵向,患者级RWD.
- 与国家癌症中心东部医院 (NCCHE) 等机构合作,建立全面的数据集.
主要成果:
- 在HER2阳性转移性结直肠癌中,SCRUM-Japan注册表已被用作对珀图祖马布和特斯图祖马布批准的外部控制数据.
- 飞铁健康 K.K.K. (FHKK) 正在从电子健康记录中开发患者级RWD,预计2023年底初始的胃肠道癌症数据集.
- 这些努力正在为日本强大的瘤RWD奠定基础.
结论:
- 在日本,瘤学RWD的开发和利用正在取得进展,监管方面的成功和正在进行的数据策划项目就是例子.
- 计划继续扩大RWD的深度和广度,以进一步提高癌症治疗疗效和患者的治疗结果.
- 瘤RWD对改善患者获得及时有效的癌症护理在日本具有重大前景.
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