Casagni Michelle, Llewellyn Nicole, Kokolus Maeve, Chan Miranda, Dingwell Robert, Chow Selina, Campbell Nancy, Elrahi Cassandra, Piantadosi Steven, Quina Andre
Clinical Quality and Data Science, The MITRE Corporation, Tampa, FL 33609, United States.
Health Protection and Preparedness, The MITRE Corporation, McLean, VA 22102, United States.
JAMIA Open. 2024 Dec 11;7(4):ooae144. doi: 10.1093/jamiaopen/ooae144. eCollection 2024 Dec.
The Integrating Clinical Trials and Real-World Endpoints (ICAREdata) project aimed to demonstrate that electronic health record (EHR) data, expressed in a standard structured format, can be extracted and transmitted to contribute to clinical research. Using the minimal Common Oncology Data Elements (mCODE), we collected standardized oncology outcome data from EHRs across 10 clinical sites and 15 trials. This report details and assesses the ICAREdata technical implementation and offers recommendations to benefit future projects with similar goals.
In the ICAREdata project, we implemented tools to collect structured clinical outcome data within EHRs, then extract and transmit the mCODE-formatted data to a secure cloud storage platform. Using the socio-technical model of health information technology, we systematically assessed the technical implementations in this multi-institutional project.
We evaluated the ICAREdata method across the 8 inter-related dimensions of the socio-technical model. For each dimension, we identified challenges and developed recommendations that implementers of future initiatives can leverage.
The ICAREdata project successfully demonstrated the feasibility of using data standards for structured data capture and transmission in clinical trials. The lessons learned from this project can accelerate the success of similar initiatives using standards-based real-world data (RWD) capture and transmission for research.
The ICAREdata project represents a step towards a future where researchers can access high-quality, standardized RWD leading to advances in research and improved care delivery.
整合临床试验与真实世界终点（ICAREdata）项目旨在证明以标准结构化格式表示的电子健康记录（EHR）数据能够被提取和传输，以助力临床研究。我们使用最小通用肿瘤学数据元素（mCODE），从10个临床站点的电子健康记录以及15项试验中收集了标准化的肿瘤学结局数据。本报告详细介绍并评估了ICAREdata的技术实施情况，并提出建议，以造福未来具有类似目标的项目。
在ICAREdata项目中，我们实施了工具来收集电子健康记录中的结构化临床结局数据，然后提取并将mCODE格式的数据传输到安全的云存储平台。我们使用健康信息技术的社会技术模型，系统评估了这个多机构项目中的技术实施情况。
我们在社会技术模型的8个相互关联的维度上评估了ICAREdata方法。对于每个维度，我们识别了挑战并制定了建议，供未来项目的实施者借鉴。
ICAREdata项目成功证明了在临床试验中使用数据标准进行结构化数据捕获和传输的可行性。从该项目中吸取的经验教训可以加速类似项目的成功，这些项目使用基于标准的真实世界数据（RWD）捕获和传输进行研究。
ICAREdata项目朝着未来迈出了一步，在这个未来中，研究人员可以获取高质量、标准化的真实世界数据，从而推动研究进展并改善医疗服务的提供。
