Department of Clinical Trial Design and Management, Translational Research Centre, Kyoto University Hospital, Kyoto, Japan.
Clin Trials. 2012 Aug;9(4):408-17. doi: 10.1177/1740774512445912. Epub 2012 May 17.
Various information technologies currently are used to improve the efficiency of clinical trials. However, electronic medical records (EMRs) are not yet linked to the electronic data capture (EDC) system. Therefore, the data must be extracted from medical records and transcribed to the EDC system. Clinical pathways are planned process patterns that are used in routine clinical practice and are easily applicable to the medical care and evaluation defined in a trial protocol. However, few clinical pathways are intended to increase the efficiency of clinical trials.
Our purpose is to describe the design and development of a new clinical trial process model that enables the primary use of EMRs in clinical trials by integrating clinical pathways and EMRs.
We designed a new clinical trial model that uses EMR data directly in clinical trials and developed a system to follow this model. We applied the system to an investigator-initiated clinical trial and examined whether all data were extracted correctly. At the protocol development stage, our model measures endpoints based on clinical pathways with the same diagnosis. Next, medical record descriptions and the format of the statistical data are defined. According to these observations, screens for entry of data, which are used both in clinical practice and for study, are prepared into EMRs with an EMR template, and screens are prepared for data checks on our EMR retrieval system (ERS). In an actual trial, patients are registered and randomly assigned to a protocol treatment. The protocol treatment is executed according to clinical pathways, and the data are recorded to EMRs using EMR templates. The data are checked by a local data manager using reports created by the ERS. After edit checks and corrections, the data are extracted by the ERS, archived in portable document format (PDF) with an electronic signature, and transferred in comma-separated values (CSV) format to a coordinating centre. At the coordinating centre, the data are checked, integrated, and made available for a statistical analysis.
We verified that the data could be extracted correctly and found no unexpected problems.
To execute clinical trials in our system, the EMR template and efficient ERSs are required. Additionally, to execute multi-institutional clinical trials, it is necessary to create templates appropriate for EMRs at all participating sites and for the coordinating centre to validate local templates and procedures.
We proposed and pilot tested a new eClinical trial model. Because our model is integrated with routine documentation of clinical practice and clinical trials, redundant data entries were avoided and the burden on the investigator was minimised. The reengineering of the clinical trial process would facilitate the establishment of evidence in the future.
目前有多种信息技术可用于提高临床试验的效率。然而，电子病历（EMR）尚未与电子数据采集（EDC）系统相连接。因此，数据必须从病历中提取并转录到 EDC 系统中。临床路径是用于常规临床实践的计划流程模式，易于适用于试验方案中定义的医疗保健和评估。但是，很少有临床路径旨在提高临床试验的效率。
我们的目的是描述一种新的临床试验流程模型的设计和开发，该模型通过整合临床路径和 EMR，使 EMR 能够在临床试验中得到主要应用。
我们设计了一种新的临床试验模型，该模型直接在临床试验中使用 EMR 数据，并开发了一个系统来遵循该模型。我们将该系统应用于一项由研究者发起的临床试验，并检查了所有数据是否都被正确提取。在方案制定阶段，我们的模型使用相同诊断的临床路径来衡量终点。接下来，定义病历描述和统计数据的格式。根据这些观察结果，使用 EMR 模板为数据录入准备了用于临床实践和研究的条目，并且为 EMR 检索系统（ERS）准备了数据检查屏幕。在实际试验中，患者进行登记并随机分配到方案治疗组。根据临床路径执行方案治疗，使用 EMR 模板将数据记录到 EMR 中。本地数据管理员使用 ERS 创建的报告检查数据。经过编辑检查和更正后，ERS 提取数据，以带电子签名的可移植文档格式（PDF）存档，并以逗号分隔值（CSV）格式传输到协调中心。在协调中心，检查、整合数据，并为统计分析提供数据。
我们验证了可以正确提取数据，并且没有发现任何意外问题。
要在我们的系统中执行临床试验，需要 EMR 模板和高效的 ERS。此外，要执行多机构临床试验，需要为所有参与站点创建适用于 EMR 的模板，并为协调中心验证本地模板和程序。
我们提出并试点测试了一种新的电子临床试验模型。由于我们的模型与常规临床实践和临床试验文档集成在一起，因此避免了冗余的数据录入，并且最大限度地减少了研究者的负担。临床试验流程的再造将有助于未来建立证据。
