设计和实施一个社区驱动的临床试验信息管理系统,用于精密瘤学设置
Georg Mathes1, Sylvia Bochum2, Patrick Werner1
1MOLIT Institute, Heilbronn, Germany.
Studies in health technology and informatics
|September 5, 2024
概括
精确瘤学试验的招聘通过社区注释试验搜索 (CATS) 平台得到加强. CATS使用快速医疗互操作资源 (FHIR) 标准为开放,互操作的临床试验注册表,提高数据质量和可搜索性.
科学领域:
- 生物医学信息学 生物医学信息学
- 临床试验管理 临床试验管理
- 精确瘤学 精确瘤学
背景情况:
- 临床试验招聘对于精确瘤学至关重要,但目前的注册表缺乏对现代试验设计和先进过的支持.
- 现有的试验注册表往往受到有限的及时性,数据质量问题以及对特定纳入标准的不充分语义搜索能力的影响.
研究的目的:
- 开发一个开放和可互操作的平台,用于管理和搜索临床试验数据.
- 改进确定适合精密瘤患者的基于生物标志物的试验的过程.
主要方法:
- 指定了一个快速医疗互操作资源 (FHIR) 实施指南 (IG) 以标准化临床试验元数据.
- 实施了社区驱动的方法来维护临床试验数据,结合开放数据源和用户注释.
- 开发了一个治理模型来管理社区贡献和责任.
主要成果:
- 开发了社区注释试验搜索 (CATS),这是一个具有开放,可互操作的信息模型的交互平台.
- CATS使得临床试验的协作注释成为科学界的综合资源.
- 该平台的术语驱动注释是为精密瘤学量身定制的,但可以转移到其他领域.
结论:
- FHIR标准和开源IG允许创建一个开放的,可互操作的临床试验注册表.
- CATS平台是首个专为现代瘤试验和机器对机器通信而设计的协作注册表.
- 在数字应用程序中,CATS有可能支持在精密瘤学试验中自动招募患者.
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