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.
Unmet medical needs, chronic diseases, ageing populations, and the emergence of personalised medicine are amongst the factors contributing to a growing healthcare demand and continuing research for effective and safe innovative medicines. The development of new medicines is recognised as critical to advance improvements in healthcare. As most new medicines are developed by the pharmaceutical industry in collaboration with academic and healthcare organisations, clinical research programs are overseen by national and international regulatory bodies. However, the discovery and development of new medicines that are effective and safe for routine use in patients have become increasingly challenging.
Pharmaceutical innovation faces numerous R&D challenges causing significant study delays and increased costs. Importantly, over the last 12 years, the average cost of conducting clinical trials has increased three-fold. In 2005, the cost of researching, developing and achieving regulatory approval for a new chemical or biological entity was estimated at € 1.1 billion. The number of drug development programs has grown by an average of 6% per year from 2002 to 2011, with growth continuing through the recent economic downturn. In parallel, clinical research is evolving and growing in complexity and labour intensity. This is, in part, due to the need to conduct large clinical trials that provide definitive evidence of clinical benefits and safety, and to the ever increasing demand from regulators and payers to also generate value-based evidence which requires conducting further studies in order to assess the “real-word” comparative effectiveness, safety and cost-effectiveness of innovative medicines compared to existing therapies.
The main bottlenecks in current clinical research include sub-optimal protocol designs, slow and lengthy patient recruitment, and labour-intensive and time-consuming clinical study conduct. Specific issues relevant to conducting clinical trials include the difficulty in evaluating patient populations and in optimizing protocol design, the effort involved in identifying suitable patients for clinical trials, the manual and redundant re-entry of data, the reliability of data sources for clinical trials, and the difficulty in detecting and reporting infrequent adverse events.
The widespread adoption of EHR systems in Europe and worldwide represent vast, rich, and highly relevant health data sources which have the potential be reused for research, to address these bottle necks. There is a growing realisation that the ability to effectively integrate and inter-operate advanced EHR systems within health care networks for clinical research purposes represents a breakthrough opportunity to enhance academic research, to speed up and streamline existing processes and to build greater efficiency. Potential applications of interest include clinical trial feasibility, patient recruitment, clinical trial execution and drug surveillance reporting.
However, such developments require acceptance by patients, the public and the health service community. The lack of interoperability between EHR systems currently limits the ability to efficiently combine the data across large populations for research analysis. Key challenges need to be overcome, at a European scale, to provide a platform to support clinical research that functions across many EHR systems, complies with ethical, legal and privacy requirements that differ from country to country, and is sustainable through a scalable business model.