Abstract
OBJECTIVES: 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. MATERIALS AND METHODS: 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. RESULTS: 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. DISCUSSION: 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. CONCLUSION: 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.