European projects, future call topics for Horizon 2020, national infrastructure programmes such as the Farr Institute and Real World Data initiatives from Pharma, all point to the growing interest amongst many stakeholders to collaborate, and tackle at a large scale, access to high-quality, integrated and appropriately protected health data to conduct research.
This presentation will look at what “Real World Data” means, the opportunities for both clinical care and clinical research to make richer uses of such data, and will examine the barriers to this scaled-up use, focusing on privacy protection concerns and the forthcoming EU Regulation, semantic interoperability, the lack of patient centricity and the overall need for research ecosystem governance.
Using two IMI projects as case studies: EHR4CR and EMIF, and drawing on complementary EC sponsored research results, the talk will consider the emerging approaches to addressing these concerns, and project their likely maturity and extent of deployment by 2020.
By considering the evolving basis for approving and licensing new medicines (such as adaptive trials and adaptive licensing), precision medicine and novel advances in health ICT, the talk will close with a picture of how clinical research and knowledge discovery might be conducted by 2025.
Professor Dipak Kalra is President of The European Institute for Health Records. He plays a leading international role in R&D on EHR architectures and systems, semantic interoperability and privacy protection. He leads the development of key ISO standards on EHR interoperability. Dipak leads the Managing Entity for the €16m IMI project EHR4CR on the re-use of EHRs for clinical research, alongside ten global pharmaceutical companies. EuroRec is also a partner in another IMI project, EMIF, developing a European clinical research platform federating population health and cohort studies. Dipak also leads an EU Network of Excellence on semantic interoperability.