临床试验数据与常规收集的数据来源的联系:一个范围审查
Mehdi NajafZadeh1, Ana Fernández Oromendia1, Mehmet Burcu2
1Medidata Solutions, A Dassault System Company, Boston, MABoston, Massachusetts.
JAMA network open
|April 29, 2025
概括
将临床试验数据与常规收集的健康数据联系起来,可以提高试验洞察力. 大多数研究都获得了数据链接的前性同意或道德豁免,证明了可行性和多样化的应用.
科学领域:
- 医疗信息学 医疗信息学
- 临床试验管理 临床试验管理
- 数据科学数据科学数据科学
背景情况:
- 从医疗互动中定期收集的数据 (RCD) 提供了有价值的见解.
- 将RCD与临床试验数据联系起来,可以更深入地了解治疗的好处,风险和成本.
- 参与者层面的联系补充了试验中的积极数据收集.
研究的目的:
- 在全球范围内审查与RCD相关的临床试验.
- 确定这些数据链接研究的用例和设计.
- 评估将临床试验数据与RCD链接的可行性和实施情况.
主要方法:
- 在PubMed和MEDLINE搜索了将临床试验与RCD (2016-2023) 联系的研究.
- 包括关于药物,疫苗,设备,程序和诊断的研究.
- 不包括意见稿,协议和行为干预研究.
主要成果:
- 包括71项研究,其中42项专注于药物/疫苗/补充剂,29项专注于设备/程序/诊断.
- 常见的使用案例包括试验后的随访 (31%),结果捕获 (26.8%),结果验证 (23.9%) 和成本分析 (16.9%).
- 45.1%获得了潜在的同意,46.5%获得了数据链接的道德豁免.
结论:
- 将临床试验数据与RCD联系起来是可行的,并在各种应用中实施.
- 未来的同意或道德豁免通常用于数据链接.
- 这种方法为将试验与RCD联系起来提供了全面的概述,增强了研究价值.
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