Enriching knowledge and enhancing care through health data

EHR2EDC

Developing a seamless and acceptable method for reusing hospital EHR data within clinical trials

 

With increased use of Electronic Health Records (EHRs), hospitals generate a vast amount of electronic health data that could be of benefit to medical research. However, due to their lack of connectivity with research platforms, there has been a huge need for the manual re-entry of data within clinical trial Electronic Data Capture (EDC) systems. This also includes data cleaning and verification … with all the ensuing disadvantages and risks: human error, workload, delay to the completion of every clinical trial and for its drug reaching patients.

 

“Hospitals perceive that 70-100% of data is duplicated across their EHR and EDC systems.”

 

The EHR2EDC project (2018-2019) was co-financed by EIT Health and by the pharma and clinical research industry. It has demonstrated a method and technology for achieving an efficient and trustworthy trial reuse of health data from hospital EHRs. Following patient informed consent, EHR data can now be automatically and securely transferred to the Electronic Data Capture (EDC) system for a study investigator to review and save. The EHR2EDC solution includes a framework to ensure GDPR compliance, the assessment of the quality of hospital EHR systems and of the EHR data quality. The data mappings required to bridge between healthcare and research standards are now open access and can be found through our resources page.

 

Benefits

Beneficiaries such as research (undustry and academic sponsored trials), hospitals and eventually patients will all see the benefits from this innovation.

 

Researchers will speed up data collection and exchange to accelerate research

 
 

Patients and their clinicians will have faster access to novel treatments

 
  Hospitals will be able to better use their own data to gain decision-supporting insights
 
 
 

Everyone will benefit from better-quality hospital and research data and systems

 

 

Read all about the outcomes and benefits of EHR2EDC

 

The EHR2EDC results in a nutshell

 

 

  • Interoperability mapping: The first validated set of the most commonly collected data in clinical trials was mapped, Common Information Model (CIM) and HL7 Fast Health Interoperability (Resources (FHIR) based interoperability profiles developed 
  • Regulatory: ISO Good Clinical Practice (GCP) and Regulatory compliance for regulated trials
  • Data governance: principles, code of practice and Standard Operating Rules to support hospitals to conform to applicable GDPR regulations
  • Technical module tested and validated
  • Multi-centric, multi-sponsor validation study (TransFAIR) successfully completed at the partner sites
 

 

TransFAIR Study: 37% of patient data transferred

TransFAIR was a synthetic clinical study that replicated the data collection of several real clinical trials drawn from multiple pharma companies in multiple disease areas. Its goal was to prove that at least 15% of data usually manually entered could be automatically transferred under control of the investigator. It was found that 37% of the necessary data could be successfully transferred. 

Discover more about this EHR2EDC validation phase, with the results of the TransFAIR Study.

 

EHR2EDC Champion Programme: amplifying the results of phase 1

Given the positive results obtained during the 2018-2019 phase of EHR2EDC, the consortium is adding a one year extension to continue the project by means of a Champion Programme.

 

OBJECTIVES of the EHR2EDC Champion Programme (2020)
  • Having a trial-ready version of EHR2EDC technology for supporting trials at Clinical Sites in Europe and North America
  • Increased % of data recovery
  • Having a common standardized oncology and cardio-vascular mapping library
  • Data quality and enrichment at partner hospitals
  • Certification and Quality Seal
  • Sustainable governance

 

Challenges tackled during EHR2EDC

Interoperability

 

Data Governance
 
Data Quality

 

Systems Quality
 
Regulatory Framework

More info

 

Consortium

This project was possible thanks to the participation of several partners and interacting with our ecosystem. More info