Trinczek Benjamin, Schulte Britta, Breil Bernhard, Dugas Martin
Institute of Medical Informatics, University of Münster, Münster, Germany.
Stud Health Technol Inform. 2013;192:1124.
In clinical trials (CTs), the process of patient recruitment (PR) is one of the main risk factors, as almost half of all trial delays are caused by problems in PR. To our knowledge, no publication in this field describes the process of PR. Therefore, weak spots and potential benefits cannot be identified. By interviewing six domain experts and modeling the workflow in a standardized way, we describe the actors, tasks and tools within PR. We compare the current workflow with Patient Recruitment System (PRS)-supported PR. The identification of eligible participants is the most complex part, but adding a PRS simplifies it by automating repetitive tasks and taking work off the Investigators' hands. This work contributes to a common understanding of the PR process.
在临床试验(CTs)中,患者招募(PR)过程是主要风险因素之一,因为几乎所有试验延迟中有一半是由患者招募问题导致的。据我们所知,该领域尚无出版物描述患者招募过程。因此,无法识别其中的薄弱环节和潜在益处。通过采访六位领域专家并以标准化方式对工作流程进行建模,我们描述了患者招募过程中的参与者、任务和工具。我们将当前工作流程与患者招募系统(PRS)支持的患者招募进行了比较。识别符合条件的参与者是最复杂的部分,但添加患者招募系统通过自动执行重复性任务并减轻研究人员的负担使其得到简化。这项工作有助于对患者招募过程达成共识。