The CodeX FHIR Accelerator is pleased to announce the successful completion of the Integrating Clinical Trials and Real-World Endpoints (ICAREdata®) initiative. Launched in 2018, this collaborative project between The Alliance Data Innovation Lab for Clinical Trials in Oncology, part of the National Cancer Institute’s National Clinical Trials Network (NCTN), and The MITRE Corporation represents a significant advancement in integrating clinical trials with real-world endpoints using electronic health record (EHR) data. Focusing on cancer clinical trials, this initiative aimed to advance oncology research by utilizing standardized, structured data to enhance research efficiency and improve patient outcomes.
ICAREdata’s Innovative Approach
The ICAREdata initiative addresses the challenge of collecting standardized point-of-care data and comparing it with conventional electronic data capture (EDC) systems. Utilizing the minimal Common Oncology Data Elements (mCODE®) standard, ICAREdata facilitates the extraction and transmission of health information in a standardized format. This approach encourages the use of real-world data (RWD) in research, minimizing manual data curation efforts and thereby improving both research efficiency and accuracy.
Technical Implementation
The technical implementation of ICAREdata involved configuring EHR tools for structured data collection and training clinicians on effective documentation practices. Due to the unavailability of HL7 Fast Healthcare Interoperability Resources (FHIR®) Application Programming Interface (APIs) for mCODE at the start of the ICAREdata project, the team utilized the ICAREdata Extraction Client—an open-source tool that facilitated the formatting and transmission of data from EHR systems to a secure cloud platform using mCODE and FHIR standards. Key lessons learned emphasized the importance of user involvement in interface design, establishing structured collaboration frameworks, and conducting comprehensive testing with synthetic data. These insights are invaluable for future projects that streamline real-world data capture and transmission.
Results and Insights
The ICAREdata initiative yielded promising results. Two critical clinical trial data elements, cancer disease status (CDS) and treatment plan change (TPC), were gathered from EHR systems at ten clinical sites across fifteen trials. The analysis revealed an overall concordance rate of 79% for TPC and 34% for CDS, which increased to 87% for CDS when disease evaluation was recorded in both systems. This alignment between EHR and EDC data underscores the potential of utilizing structured EHR data to enhance the accuracy and efficiency of clinical research.
The Future: Data-DIRECT Initiative
Building on the success of ICAREdata, the Data-DIRECT use case is set to further advance oncology research by developing a common, standards-based application programming interface (API). This innovative approach aims to conduct clinical trials without the traditional reliance on case report forms (CRFs).
For organizations and researchers interested in collaborating on these innovative projects, the CodeX community remains open to new partnerships. Contact the CodeX Program Management office for more information (pmo@hl7codex.org).
Conclusion
The ICAREdata project marks an important milestone toward a future where researchers have access to high-quality, standardized real-world data, driving progress in research and improving care delivery.
This work has been documented in two notable publications: “Feasibility of Structuring Electronic Health Record Data to Facilitate Real-World Data Research: ICAREdata Methods Applied to Multicenter Cancer Clinical Trials” published in Cancer, and “Integrated Electronic Health Record Tools to Access Real-World Data in Oncology Research” featured in JAMIA Open.
Resources
- George S, Campbell N, Hillman SL, et al. Feasibility of structuring electronic health record data to facilitate real-world data research: ICAREdata methods applied to multicenter cancer clinical trials. Cancer. 2024; 1-11. doi:10.1002/cncr.35528
- Casagni M, Llewellyn N, Kokolus M, et al. Integrated electronic health record tools to access real-world data in oncology research. JAMIA Open. 2024. https://doi.org/10.1093/jamiaopen/ooae144
- Visit the CodeX Confluence site to read more about the EHR Endpoints for Cancer Clinical Trials
- To learn more or get involved in the upcoming Data-DIRECT use case team, visit its confluence page.
