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
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
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
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
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:
Wilhelms University Münster (Prof. Dr. Martin Dugas)
- Friedrich-Alexander University Erlangen-Nuremburg (Prof. Dr. Hans-Ulrich
- Heinrich-Heine University Düsseldorf, as representative for ECRIN
(Prof. Dr. Christian Ohmann)
- XClinical GmbH
- TMF e.V.
- Website EHR4CR project
- TMF-News "Changing the way we understand healthcare and medicine" (January 2012)
- TMF-News "Europeans Jointly Promote Future Use of Data from Electronic Health Records for Research" (Januar 2012)