Case Report from the EHR4CR Project
collected clinical data, which may limit the suitability of the data for use in clinical trials.
Notably, the results of this e-survey clearly reveal the expectation for the EHR4CR platform to be value-driven rather than cost-driven. This means that its services need to be demonstrably of a high quality and deliver added benefits, improved efficiency, and value for money to its customers and end users. In particular, the most significant benefits for research organizations, patients, and society of re-using EHR data for clinical research were identified by the respondents as the delivery of high-quality and cost-effective solutions, optimization of clinical research processes, and elimination of non-value-added tasks (redundant data entry). The results also revealed that such improvements were expected to lead to greater drug development efficiency, faster access to safe and effective medicines, enhanced patient safety, and best practices in e-clinical research through the proposed accreditation and certification programs.
While the results of this EU e-survey provide useful information, they are nonetheless limited in scope. They will be complemented by supplemental environmental scan initiatives undertaken by the EHR4CR consortium, including semi-structured interviews with EU academic experts, as well as an ongoing consultative process with public and private EU stakeholders over the duration of the project.
Conclusions
There is increasing societal acceptance of the need for clinical research and of the potential value of re-using EHR patient-level data to optimize research efforts. In parallel, society in general, healthcare systems and the pharmaceutical industry are critically concerned about managing costs more efficiently and providing timely access to safe and effective innovative medicines.
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The rapid advancement of health information technologies (including EHRs) now offers remarkable opportunities to optimize clinical research potential, to streamline existing processes, and to enhance overall drug development efficiency and access to innovative medicines in Europe. In this context, the EHR4CR project intends to meet the ambitious objective of establishing a scalable pan-European platform to enable the re-use of EHR data to support the design and execution of clinical trials and the monitoring of the safety of medicines.
This survey confirms the high interest and relevance of the EHR4CR project with regard to EU stakeholders’ respective needs and incentives for delivering sustainable and cost-effective solutions in Europe. These promising possibilities and the complexity inherent to the EHR4CR platform also require carefully addressing current opportunities and challenges with continuous support and input from all relevant stakeholders to enable the successful implementation of a pan-EU EHR4CR capability and sustainable business model at project completion.
Considering that the EHR4CR platform will need to be deployed and interface with a wide range of systems and services to support an end-to-end user experience, this EU e-survey provides valuable information towards achieving the development and implementation of EHR4CR services and of a sustainable and scalable business model. The results of this e-survey also address the many opportunities and significant challenges ahead, including ensuring interoperability in compliance with privacy protection, regulatory, legal, and ethical requirements, and policies across Europe. Another challenge is the near-universal downscaling of many national e-health programs, which may limit the opportunity to extend the richness and interoperability of EHR systems and of the infrastructure to enable them to communicate at a regional or national level. ■
An Examination of Pragmatic Issues, Michael Kahn, University of Colorado.
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