Ghent, Belgium – 29 July 2024.
The European Institute for Innovation through Health Data (i~HD) has launched the eSource Scale Up Task Force, aimed at transforming clinical trial data collection. The task force features i~HD invitation-only members from industry and healthcare organization including AstraZeneca, Cambridge University Hospitals (CUH), Johnson & Johnson, Memorial Sloan Kettering Cancer Centre (MSK), Regeneron®, and Sanofi.
The mission is to collectively drive and scale eSource implementation, revolutionising clinical trials worldwide. The collaborative model builds on pioneering projects like EHR4CR, EHR2EDC, and EU-Pearl, offering impartial recommendations and shared experiences across vendors, pharmaceutical companies, and hospitals.
Currently, up to 70% of clinical trial data is duplicated between research systems and hospital Electronic Health Records (EHRs), accounting for about 20% of study costs. With HL7 FHIR standards and SMART on FHIR APIs, large-scale electronic patient data transfer to study databases is now feasible.
EHR to EDC (Electronic Health Record to Electronic Data Capture) or EHR as eSource, streamlines the transfer of EHR data for clinical research. Conducted with patient consent and quality checks, this process meets regulatory eSource requirements, integrating data into an EDC system or the sponsor’s study database without replacing site staff or duplicating data capture.
Automated data transfer minimizes site burden, accelerates trial timelines, improves data quality, and enhances patient safety. Additionally, it significantly reduces the need for Source Data Verification (SDV), contributing to overall cost savings. Integrating EHR and EDC systems strengthens relationships with investigational sites, optimizes protocols, and enhances clinical trial efficiency.
Coordinated by i~HD, this initiative aims to engage stakeholders including hospitals and other players like Vulcan, TransCelerate, Society of Clinical Data Management (SCDM), EFPIA, EMA, FDA, and leading EHR-to-EDC vendors, as well as EHRs vendors. This initiative represents a visionary leap towards seamless EHR integration in clinical trials. Deliverables will include recommendations, publications, and joint presentations from workshops and webinars aimed at informing key decisions makers for a coordinated efforts in scaling up eSource technology.
Contact Information:
Christophe Maes
christophe.maes@i-hd.eu
