This project will enable the collection of clinical data from the electronic health records (EHRs) of several hospitals, to develop a system that can improve the efficiency of medical research, including research involving real world data. The EHR2EDC solution will enhance global research and accelerate access to treatment innovations.

Origins

With increased use of EHRs, hospitals generate a vast amount of eHealth data that could benefit medical research, but there are inefficiencies. Nearly 50% of data is duplicated across EHRs and the electronic data capture systems (EDCs) used for clinical trials. This wastes time as it requires data cleaning and verifications activities. Researchers need to be able to re-use health data ethically and efficiently across multiple systems.

Team

The consortium behind EHR2EDC is a collaborative effort driven by industry partners, hospital partners, an SME and a not-for-profit organisation aiming to promote and catalyse the most efficient and trustworthy uses of health data and interoperability, for optimising health and knowledge discovery.

The project

EHR2EDC leverages a pre-competitive industry collaboration that brings together global industry actors to improve data sharing for research. This project scales up and adds value to InSite™, a clinical research technology platform developed by the IMI EHR4CR project to facilitate secondary use of hospital EHR data.

EHR2EDC (Electronic Health Records to Electronic Data Capture systems) will allow for the automatic capture of data from different hospital record systems. This will mean approximately 15% of the data of clinical protocols that was previously re-entered manually can be transferred automatically. The system will reduce human errors, the workload of stakeholders, the complexity of data entry and the amount of time spent on data collection. The solution developed will be fully compliant with relevant regulatory requirements such as GxPs and GDPR.

This project will deliver:

• Clinical data standards and mapping-library algorithms, using FHIR (Fast Healthcare Interoperability Resources) profiles, to enable data interoperability between EHRs and EDC systems.
• Regulatory acceptance criteria to enable EHR data to be used as an eSource in support of clinical development studies.
• InSite Module S3, which is EHR2EDC software to allow site coordinators and investigators to reduce manual duplicative data entry.
• Conduct of Pilot clinical trials at project members’ hospitals, to fully validate EHR2EDC capabilities.
• Publications and presentations to promote project outputs, to be used within the biomedical research community and foster adoption of developed standards.

Impact

EHRs are allowing a pivotal change in clinical trials and patient care, promising huge benefits for medical science, patients and citizens. This project enables better use of EHRs by:

• reducing trial complexity, enabling near real-time patient safety monitoring, and reducing costs of new medicine;
• increasing European attractiveness to access larger patient data through a large EHRs network;
• enabling health learning systems to improve patient care and reduce costs.

Why this is an EIT Health project

The way this project uses cross-sector networking and Europe-wide cooperation to promote research and innovation goes to the core of what EIT Health is all about. The project is also in keeping with the EIT Health Focus Area of “Harnessing the Power of Real World Data”, because it uses the data naturally generated by hospitals to drive innovation.

External Partners

• ICON
• The European Institute for Innovation through Health Data (i~HD)
• Custodix
• Hospital 12 de Octubre (Madrid, Spain)
• Hannover Medical School (Hannover, Germany)
• Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) (Meldola, Italy)