现实世界的证据:拉丁美洲决策的经验和挑战
Sebastián García Martí1, Andrés Pichón-Riviere1, Federico Augustovski1
1Institute for Clinical Effectiveness and Health Policy (IECS-CONICET), Buenos Aires, Argentina.
International journal of technology assessment in health care
|December 18, 2023
概括
现实世界证据 (RWE) 越来越多地用于拉丁美洲的健康技术评估 (HTA). 制定HTA中RWE的指导方针可以扩大其在该地区的应用.
科学领域:
- 卫生技术评估 卫生技术评估
- 现实世界的证据.
- 卫生经济学 卫生经济学
背景情况:
- 卫生技术评估 (HTA) 过程旨在优化卫生系统的资金.
- 现实世界证据 (RWE) 越来越多地与临床试验一起使用.
- 2022年拉丁美洲政策论坛的重点是RWE在HTA中的作用.
研究的目的:
- 探索将RWE纳入HTA和拉丁美洲决策的实用性.
- 确定RWE在区域HTA过程中的当前和潜在应用.
主要方法:
- 该研究基于一个背景文件.
- 在参与者中进行了一项调查.
- 包括论坛国家代表的审议工作.
主要成果:
- 拉丁美洲对HTA的RWE越来越感兴趣,但没有具体的当地指导方针.
- 目前在HTA中使用RWE仅限于对报告进行上下文化,评估不良事件和成本估计.
- 潜在的未来用途包括风险分担协议,评估现实世界的表现,评估特定结果 (例如,生活质量),并为经济模型提供信息.
结论:
- 参与者一致认为,在HTA中扩大RWE/RWD应用的巨大潜力.
- 在HTA中开发用于RWE的规范框架被认为是有帮助的.
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