Duke Clinical Research Institute, Duke University, Durham, NC, USA.
Duke Clinical Research Institute, Duke University, Durham, NC, USA.
Contemp Clin Trials. 2022 Jun;117:106789. doi: 10.1016/j.cct.2022.106789. Epub 2022 May 8.
Randomized controlled trials (RCT) are the gold standard for evaluating the effectiveness and safety of interventions and treatments, yet traditional clinical trials have relied on cumbersome and redundant processes such as electronic data entry which involves manual abstraction of already available electronic health record (EHR) data. This review focuses on the opportunities to expand the use of EHR data for pragmatic clinical trials using methods and lessons learned from the Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study, the demonstration project from PCORnet® (the National Patient-Centered Clinical Research Network).
随机对照试验(RCT)是评估干预措施和治疗方法有效性和安全性的金标准,但传统的临床试验依赖于繁琐且重复的过程,例如电子数据录入,这涉及到从已经可用的电子健康记录(EHR)数据中手动提取。本综述重点介绍了使用从 PCORnet®(国家以患者为中心的临床研究网络)的 ADAPTABLE 研究(展示项目)中学到的方法和经验,来扩大使用 EHR 数据进行实用临床试验的机会。