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Creating Added Value Together To Link Up Medical Care and Research

EHR4CR project launches co-creation process in Berlin with first stakeholder group

November 25, 2013. This market does not follow the usual principles: While on the one hand there are many patients who would like to participate in a clinical trial, research projects regularly fail due to the fact that it is impossible to identify or recruit sufficient suitable trial volunteers. One of the activities made more difficult as a result of this is the development of new medicines. The European project "Electronic Health Records for Clinical Research" (EHR4CR) addresses the structural hurdles that so far have prevented the problem from being solved, and integrates the relevant user groups into the development process. At the EHR4CR annual conference, which took place at the TMF in Berlin from November 18 to 20, 2013, the latest results and further planning of the project were discussed with the stakeholder group.

The EHR4CR project is being funded with a total of 17 million euros within the scope of the Innovative Medicines Initiative (IMI), one of the largest public-private partnership projects in Europe. The objective of the project is to enable secondary use of data from electronic health records for future clinical research and thus speed up the development of better and safer medicines. The initiative is being jointly funded by the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

  

Challenges are interoperability, ethical issues, and confidence in data

At the Stakeholder Awareness Session on November 20, 2013, representatives of contract research organizations (CROs) and companies from the medical IT sector contributed their requirements to the discussion. As the project proceeds, further stakeholder meetings are planned, also with representatives of hospitals and patient groups.

Prof. Dipak Kalra (University College London), who chaired the conference together with Andreas Schmidt (Hoffmann La Roche), cited the following principal hurdles that had been hindering the success of solution approaches to date: interoperability, legal issues (data protection) and ethical issues, and the integrity and trustworthiness of data. He said that in the project these difficulties were being interpreted as challenges and that the user groups were therefore being integrated into the development process at a very early stage.


 
Prof. Dipak Kalra (University College London, left) and Andreas Schmidt (Hoffmann La Rochche, right) chaired
the EHR4CR meeting 2013 in Berlin.

   

Personal data remains within the hospital administering treatment

The EHR4CR project involves a total of 10 companies from the pharmaceutical industry, 11 university hospitals, plus numerous academic groups and patient organizations. Together, the partners are establishing a technical platform that is making it easier to link electronic health records to research platforms and networks in the healthcare sector.

In doing so, a great deal of importance is being attached to data protection in particular: Dipak Kalra explained that the platform was being created in such a way that analysis of the de-identified data takes place at an early stage, in the relevant hospital. All disclosure of person-related data takes place only with explicit consent from the patient, who, as previously, is asked by his attending doctor whether he wishes to give his consent. 
 

EHR4CR institute is to ensure trustworthiness of data

In the EHR4CR project, special attention is being paid to the development of a business model in order to ensure long-term operation of the platform, even when IMI funding has ended. The key element of the sustainability concept is the planned EHR4CR institute, one of the responsibilities of which will be to ensure the trustworthiness of data by means of accreditation and certification. The institute will take the form of a not-for-profit organization, the operation of which will be financed by various charges.

During the event it became clear that the project has already been playing a major role, for example in policy decisions taken by the European Medicines Agency (EMA), and after that, ones also taken by the Food and Drug Administration (FDA), as was reported by Bron W. Kisler representing the Clinical Data Interchange Standards Consortium (CDISC).

The next steps to be taken in the project will be the optimization of existing tools and platforms for data transfer and the development of new services. Another two stakeholder meetings are also scheduled for 2014.


About 60 project partners took part in the EHR4CR
Steering Committee meeting on November 19, 2013.
Every work package presented their results
in interactive booths during the meeting.


About the EHR4CR projekt

The EHR4CR project is being funded with a total of 17 million euros within the scope of the Innovative Medicines Initiative (IMI) over the period from 2011 to 2014. IMI is one of the largest public-private partnership projects in Europe with the aim of speeding up the development of better and safer medicinal drugs. The initiative is being jointly funded by the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA).  

German project partners are:

  • Westfaelische Wilhelms University Münster (Prof. Dr. Martin Dugas)
  • Friedrich-Alexander University Erlangen-Nuremburg (Prof. Dr. Hans-Ulrich Prokosch)
  • Heinrich-Heine University Düsseldorf, as representative for ECRIN (Prof. Dr. Christian Ohmann)
  • XClinical GmbH
  • TMF e.V.

Further Informationen

  1. Website EHR4CR project
  2. TMF-News "Changing the way we understand healthcare and medicine" (January 2012)
  3. TMF-News "Europeans Jointly Promote Future Use of Data from Electronic Health Records for Research" (Januar 2012)

 

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