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模拟比较瘤学试验与现实世界的证据研究 (ENCORE):瘤学的过程开发和方法考虑现实世界的数据.

Janick Weberpals1, Sebastian Schneeweiss1, Kenneth L Kehl2

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该ENCORE项目模拟了12项瘤学试验,使用来自电子健康记录的真实数据. 这项研究评估了现实世界证据 (RWE) 如何可靠地告知癌症治疗的有效性和安全性,并补充了传统试验结果.

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科学领域:

  • 在瘤学瘤学.
  • 现实世界的证据研究研究.
  • 临床试验模拟临床试验模拟

背景情况:

  • 现实世界证据 (RWE) 通过评估日常实践中的医疗干预来补充随机对照试验 (RCT).
  • 电子健康记录 (EHR) 数据使RWE在瘤学方面的研究成为可能,因为索赔数据不足.
  • 之前的DUPLICATE倡议工作建立了模拟RWE试验的方法,用于非瘤学指示.

研究的目的:

  • 将试验模拟方法扩展到瘤学,使用真实世界数据 (RWD).
  • 设计和选择试验,以模拟与现实世界证据的比较瘤学试验 (ENCORE) 项目.
  • 评估EHR数据是否适合模拟瘤学RCT并得出因果结论.

主要方法:

  • 在四种癌症类型 (非小细胞肺癌,乳腺癌,结肠直肠癌,多发性髓瘤) 中对12个比较性瘤学RCT的模拟.
  • 使用四个瘤学专业的EHR数据库.
  • 系统评估数据适应性,研究设计和统计分析.
  • 预先注册研究方案.
  • 评估RCT和模拟试验治疗效果估计之间的一致性.
  • 广泛的敏感性分析与RCT结果进行基准测试.

主要成果:

  • 该ENCORE项目旨在利用专门的EHR数据库模拟四种瘤病症的12个RCT.
  • 强调系统的数据适应性评估和协议预注册.
  • 预先规定的标准将评估RCT与其模拟对手之间的协议.
  • 敏感性分析将RWD发现与RCT结果进行基准比较.

结论:

  • 该ENCORE项目旨在提高对RWE在瘤学试验模拟中的理解.
  • 它将为RWD研究的测量,设计和分析做出决定.
  • 这些发现将指导使用EHR数据的模拟瘤学试验结果的解释.