Brigham and Women's Hospital, Alliance for Clinical Trials in Oncology Foundation, Boston, MA, USA.
MITRE Corporation, Bedford, MA, USA.
Clin Trials. 2020 Jun;17(3):237-242. doi: 10.1177/1740774520913819. Epub 2020 Apr 8.
Clinical trials provide evidence essential for progress in health care, and as the complexity of medical care has increased, the demand for such data has dramatically expanded. Conducting clinical trials has also become more complicated, evolving to meet increasing challenges in delivering clinical care and meeting regulatory requirements. Despite this, the general approach to data collection remains the same, requiring that researchers submit clinical data in response to study treatment protocols, using precisely defined data structures made available in study-specific case report forms. Currently, research data management is not integrated within the patient's clinical care record, creating added burden for clinical staff and opportunities for error. During the past decade, the electronic health record has become standard across the US healthcare system and is increasingly used to collect and analyze data reporting quality metrics for clinical care delivery. Recently, electronic health record data have also been used to address clinical research questions; however, this approach has significant drawbacks due to the unstructured and incomplete nature of current electronic health record data. This report describes steps necessary to use the electronic health record as a tool for conducting high-quality clinical research.
临床研究为医疗保健的发展提供了至关重要的证据，随着医疗复杂性的增加，对这类数据的需求也大幅扩大。进行临床研究也变得更加复杂，需要不断发展以应对提供临床护理和满足监管要求方面日益增加的挑战。尽管如此，数据收集的总体方法仍然保持不变，要求研究人员根据研究治疗方案提交临床数据，使用特定研究案例报告表中提供的精确定义的数据结构。目前，研究数据管理并未整合到患者的临床护理记录中，这给临床工作人员增加了负担，并增加了出错的机会。在过去十年中，电子健康记录已成为美国医疗保健系统的标准，并越来越多地用于收集和分析临床护理交付数据报告质量指标。最近，电子健康记录数据也被用于解决临床研究问题；然而，由于当前电子健康记录数据的非结构化和不完整性质，这种方法存在显著的缺陷。本报告介绍了将电子健康记录用作进行高质量临床研究工具所需的步骤。
