在亚洲产生适合目的的现实世界的证据:我们距离缩小差距有多远?
Wen-Yi Shau1, Sajita Setia2, Salil Shinde1
1Medical Affairs, Emerging Asia, Pfizer Corporation Hong Kong Limited, Quarry Bay, Hong Kong.
Perspectives in clinical research
|August 9, 2023
概括
亚洲的真实世界证据 (RWE) 收集非常重要,因为在试验中代表人数不足. 对于监管和偿还决策,尽管存在数据隐私方面的挑战,但仍需要标准化实践和能力.
科学领域:
- 卫生经济学和研究成果研究成果
- 临床试验方法论 临床试验方法论
- 健康 数据科学 数据科学
背景情况:
- 随机对照试验 (RCT) 往往缺乏现实世界的概括性,限制了它们对不同患者群体的适用性.
- 现实世界数据 (RWD) 研究旨在获得更广泛的人口相关性,但在管理混因素和保持内部有效性方面面临挑战.
- 亚洲人群在全球RCT中代表性不足,这凸显了该地区需要强有力的真实世界证据 (RWE) 生产的需要.
研究的目的:
- 为了强调亚洲对高质量的现实世界证据 (RWE) 的关键需求.
- 在亚洲医疗保健系统中确定RWE生成和采用方面的挑战.
- 倡导采取集体行动,为亚洲的RWE建立标准化实践.
主要方法:
- 对随机对照试验 (RCT) 关于外部有效性的当前局限性的分析.
- 对利用真实世界数据 (RWD) 进行因果推理所面临的挑战的研究.
- 亚洲国家对RWE的监管和报销格局的审查.
- 评估数据隐私和电子医疗记录 (EMR) 的技术进步.
主要成果:
- 试验试验具有有限的外部有效性,无法完全代表现实世界的患者旅程和结果.
- 有效管理外部因素和混因素对于有效的RWD研究至关重要.
- 亚洲面临着一项双重挑战:在全球试验中代表性不足,并落后于采用RWE的基本指导.
- 在亚洲开发RWE受到不断变化的隐私法和对增强数据基础设施的需求的阻碍.
结论:
- 在亚洲产生高质量,适合目的的RWE对于为临床和监管决策提供信息至关重要.
- 解决数据隐私问题和建立明确的监管途径至关重要.
- 工业,政府和研究机构之间的协作努力是建立亚洲RWE能力的必要条件.
- 标准化实践对于在亚洲范围内有效开发和实施RWE至关重要.
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