在临床试验中使用医疗保健系统数据来获得结果:在设计阶段需要考虑的问题
Alice-Maria Toader1, Marion K Campbell2, Jennifer K Quint3
1MRC-NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool, Liverpool, UK. Sgatoade@liverpool.ac.uk.
现在已经有了关于在临床试验中使用医疗保健系统数据 (HSD) 的指导. 这有助于试验者决定何时以及如何使用HSD,以获得更好的试验设计和结果.
科学领域:
- 临床试验方法论 临床试验方法论
- 医疗保健服务研究 医疗服务研究
- 在医疗保健中的数据科学.
背景情况:
- 医疗保健系统数据 (HSD) 越来越多地被用于临床试验,补充或取代传统的数据收集方法.
- 该PRIMORANT研究解决了在英国临床试验中使用HSD作为结果数据的指导需求,这是试验社区的优先事项.
研究的目的:
- 确定在最终决定在临床试验中使用HSD作为结果数据之前需要考虑的关键问题.
- 为临床试验人员制定关于在临床试验设计和交付中使用HSD的实用指南.
主要方法:
- 这项研究分为三个阶段,包括一个初始研讨会,一个广泛的咨询练习和一个最后的讨论研讨会.
- 咨询包括临床试验单位工作人员,试验人员,方法学家,临床医生,资助小组和数据提供者.
- 通过案例研究和突破小组讨论来探讨问题.
主要成果:
- 确定的主要主题包括数据有效性,及时性,内部试点,数据共享,实用性和决策.
- 大多数受访者 (95%) 认为制定指导是可行的.
- 制定了指导,涵盖术语,可行性,内部试点,进一步的数据共享和数据存档.
结论:
- 该研究提供了指导,以告知关于使用HSD用于临床试验结果的决策.
- 协助试验人员与注册表和HSD提供商合作,以提高试验设计和执行.
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