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EHR2EDC: A revolution in collecting and using health data in clinical research

CLC France , Innovation by Design , CLC/InnoStars News , Activity/Project News

EHR2EDC: A revolution in collecting and using health data in clinical research

A breakthrough innovation - EHR2EDC: Electronic Health Records to Electronic Data Capture systems

04 June 2018
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This project is supported by EIT Health coordinated by Sanofi in line with the IMI EHR4CR initiative. This is the first international project to enable the automated collection of patient data from Electronic Health Records (EHRs) in clinical trials. The project is conducted jointly by pharmaceutical companies, hospitals and small and medium-sized enterprises (SMEs).

 

This technological innovation will make it possible to collect, after anonymisation, hospital EHRs data transparently for the sender and make it accessible to clinical trial investigators. All of these activities are in accordance with good clinical practice and regulations related to personal data protection and the new Global Data Protection Regulation (GDPR).

An innovation with a high added value

EHR2EDC (Electronic Health Records to Electronic Data Capture systems) will reduce the workload of stakeholders, the complexity of data entry, the human errors due to manual data entry and the execution time of data collection! This new technology, in its first iteration,  will allow the automatic capture of about 15% of the data of clinical protocols, previously re-entered manually. For example, if you count 1 minute of data entry, out of 100 Phase II, III, or IV clinical trials, the reduction in time for entering and validating the data represents a saving in almost €10 million.

An incredible consortium to develop new skills
The consortium brings together academic and industrial partners around this project in order to co-create the solution and promote innovations in the pre-competitive stage. The EHR2EDC partnership includes six EIT Health Partners, four pharmaceutical companies (Sanofi*, Janssen, UCB, Astra Zeneca), one academic hospitals and organisation (APHP*, INSERM*) - *EIT Health France Partners -, other European hospital centres, a CRO (Clinical Research Organization: ICON). The i-HD Institute for Health Data Innovation and a technology company (Custodix).

Going through stages in a steady rhythm 
EHR2EDC was submitted and accepted as an Innovation By Design project in the EIT Health 2017 Call for Projects. Project governance and regular meetings are set up. The first Workshop was organized by Sanofi in its premises in Gentilly. It took place in February 2018, in the presence of all the project partners, within a new open space dedicated to innovation: 39 Bis.

An innovative approach was set up with the help of Cognizant to ease the workshop, which brought together very heterogeneous audiences with very different worlds of representation. After a day and a half, the participants were able to take ownership of the project, build and commit themselves together on the roadmap for the greatest satisfaction of the partners.

The next workshop will be organised by Janssen and will take place at the end of June, still in the 39Bis place with original animations already planned. By the end of 2018, the first tests will be performed. The connection with IMI and TransCelerate initiatives is underway to optimise efforts and create synergies with these other consortiums

The project is launched into four European hospitals, enabling the integration and dissemination of innovation to begin. The operational process will then begin in 2019 with the validation of the technological protocol, the finalisation of tests andthe implementation of the first clinical protocols benefiting from this innovation. The data collection will begin in the second half of the year and it will be used for pilot clinical studies to determine the capabilities of EHR2EDC. The training programme for hospitals will be developed with the i-HD.

A bet for clinical research
EHR2EDC is not only a way to digitalise clinical trials but it is also a real opportunity to revolutionise the way clinical trials are conducted and to encourage biomedical research.

Read more about the project here.

For further enquiries contact:

Albane Pariset, albane.pariset@eithealth.eu