Electronic Health Records for Clinical Research
The EHR4CR project (2011-2016) with a budget of +16 million Euros, has involved 35 academic and private partners (10 pharmaceutical companies) and is one of the largest of the IMI PPPs in this area. The consortium also included 11 hospital sites in France, Germany, Poland, Switzerland and the United Kingdom. It was part-sponsored by the European Commission through the Innovative Medicines Initiative (IMI).
The EHR4CR project has developed a robust and scalable platform that can utilise de-identified data from hospital EHR systems, in full compliance with the ethical, regulatory and data protection policies and requirements of each participating country. The EHR4CR platform supports distributed querying to assist in clinical trials feasibility assessment and patient recruitment. The platform can connect securely to the data within multiple hospital EHR systems and clinical data warehouses across Europe, to enable a trial sponsor to predict the number of eligible patients for a candidate clinical trial protocol, to assess its feasibility and to locate the most relevant hospital sites. Applications for internal use are offered to connected hospitals to assist them to efficiently identify and contact the patients who may be eligible for particular clinical trials. Contrary to other initiatives, EHR4CR designed a solution which is compliant to EU legislation and respects the position of hospital and patients. One of the key aspects is that patient level data never leaves the connected hospitals.
This development has required securing acceptance from the patients, the public and the research and health service communities. Therefore, in parallel to the technical developments, senior level decision makers, ethics boards and industry executives and scientists, have been involved in consultations to provide strategic insights into the most robust and acceptable technical and procedural approaches that should be taken to ensure privacy protection and compliance with European and national/regional regulations on data protection.
EHR4CR has shown that such a platform can significantly improve the efficiency of designing and conducting clinical trials, reducing time and costs, reducing administrative burdens, optimising protocol feasibility assessments, accelerating patient recruitment, making study conduct more efficient, enabling the participation of European hospitals in the more clinical trials and thereby potentially increasing research income.
The European Institute for Innovation through Health Data (i~HD) http://www.i-hd.eu is a not-for-profit organisation that has been established in 2015, arising in part out of the EHR4CR project, to develop and promote best practices in the governance, quality, semantic interoperability and uses of health data, including its reuse for research. An important role of i~HD is to provide independent governance oversight of clinical research platforms and their expanding networks of hospitals.
The first EHR4CR service provider, Custodix https://www.custodix.com, is now launching its operational platform, InSite (www.insiteplatform.com), for Europe-wide deployment, to be governed by i~HD. An early adopter Champion Programme has been launched as a first step in building a pan-European network connected to the InSite Platform. The objectives are to start building a network and community of hospitals open to data re-use for research, to further validate and improve the technology and to refine the business model, creating a win for all stakeholders. The Champion Programme serves at proving the value of Real World Data for clinical research and the InSite technology on a wide scale.
If you want to read more about the project results, please visit the i-HD website - www.i-HD.eu