Case Report from the EHR4CR Project


Electronic Health Records for Clinical Research (EHR4CR) is a four-year project sponsored by European public funds through the Innovative Medicines Initiative under the 7th Framework Program of the EU Commission and by in-kind contributions from the European pharmaceutical industry. This public–private research initiative involves EU experts from academia and from the European Federation of Pharmaceutical Industries and Associations.


The EHR4CR project will deliver an innovative platform and a sustainable business model to enable the re-use of data from electronic health records (EHRs) for clinical research purposes in Europe. More specifically, the EHR4CR project will develop a state-of-the-art interoperable platform to enable heterogeneous EHR systems to re-use patient data for clinical research, in full compliance with applicable legislative, regulatory, ethical, and privacy protection requirements and policies across Europe. For the first time, the EHR4CR platform and business model will provide a systematic, structured, and scalable approach to the re-use of EHRs data for clinical research. Ultimately, the EHR4CR platform is intended to streamline existing clinical research processes, attract further research and development investments, and optimize access to innovative medicines in Europe. As a result, the re-use of EHR data will benefit healthcare professionals, clinical researchers, regulators, patients, and society.


However, these solutions will need to address specific needs and challenges and secure acceptance from patients, the public, and the health service community. As part of a larger environmental scan initiative, this article presents the results of an EU electronic survey (e-survey) recently conducted among EU stakeholders from the public and private sectors to address the key opportunities and challenges pertaining to the optimal development and implementation of EHR4CR services in Europe.


Background


The development of new medicines is critical to maintain and advance improvements in healthcare. However, the discovery of new medicines has become increasingly challenging. Current unmet medical needs, ageing populations, long-term management of chronic diseases, and personalized medicines contribute to an increasing healthcare demand. The concurrent escalation in healthcare expenditures also contributes to building unprecedented pressure on healthcare systems in Europe and around the world.


In parallel, the average cost of conducting clinical trials has increased three-fold over the last 12 years.1


In 2006, the cost of researching,


developing, and achieving regulatory approval for a new chemical or biological entity was estimated at €1.1 billion.2


The total research


and development (R&D) cost across the industry was estimated at €710–790 billion in 2007, with an annual growth rate of 10.2–13.6 % since 2003.3


Clinical research accounts for around 75 % of these R&D costs. The lengthy clinical development processes (average eight to 10 years) combined with the ever more challenging market access conditions for new compounds also negatively impact the pharmaceutical sector.


Furthermore, between 1990 and 2008, R&D investments in the US grew by 5.6-fold, while in Europe it only grew by 3.5-fold. This confirms Europe’s relative lack of attractiveness for pharmaceutical R&D


iHEALTH CONNECTIONS


investment. Today, there is rapid growth in the research environment in emerging economies such as China and India, resulting in closure of R&D sites in Europe and opening of new sites on the Asian continent.2


Clinical research is also growing in complexity and labor intensity. This is, in part, attributable to the need to conduct large clinical trials that provide definitive evidence of clinical efficacy and safety. There is also a rising demand to assess comparative effectiveness in routine medical practice, which may require conducting extended non-interventional studies. Further issues include the difficulty of targeting the right patient populations, optimizing study protocol designs, identifying suitable patients for clinical trials, re-entering redundant clinical data manually, and detecting and reporting infrequent adverse events in a timely manner. All these factors explain the motivation from developers to transform current clinical research models to bring innovative medicines to market faster and at lower cost.


Recent developments in EHRs now increasingly provide opportunities to re-use the data they contain for clinical research purposes. The considerable progress made in seamlessly integrating EHRs within existing healthcare networks offers new possibilities for private- and academic-sector researchers to conduct clinical trials more efficiently. However, issues remain. Access to EHRs for research is often limited, and those that are available are not always representative of the whole population from which patients may be recruited. It is currently very difficult to perform research queries across multiple EHRs and turnaround times are lengthy; this makes rapid, dynamic ‘what-if’ analysis almost impossible.


This is why state-of-the-art, data-driven protocol feasibility has been only slowly adopted across wide portfolios or entire research organizations. The consequences of not optimizing protocols are: increased protocol amendments, slower than expected enrolment, costly changes to add new sites and countries, and, sometimes, even failed trials. Almost half of all trial delays are caused by participant recruitment problems4


and


the percentage of studies that complete enrolment on time is extremely low across all clinical trial markets: 18 % in Europe, 17 % in Asia-Pacific, 15 % in Latin America, and 7 % in the US.5


Today, clinical trial data are entered into dedicated electronic clinical trial systems and the same information is often also entered into the institution’s EHR system. Connecting healthcare and clinical trial systems for data exchange could reduce or even avoid the redundant data entry occurring today. Various studies have established that over 40 % of clinical trial data are entered into the patient’s health record, the clinical trial EDC system, and, possibly, a third paper copy.6,7


Investigational sites


estimate that over 70 % of data are duplicated between EHR and clinical trial systems.8


There is now a growing realization that the ability to effectively integrate and interoperate advanced EHR systems within healthcare networks represents a unique opportunity to enhance academic research, to speed up existing processes, and to build greater efficiency. These advances promise to address significant unmet medical needs more expediently, to improve patient safety, and to optimize access to innovative medicines for better health outcomes.


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