Title: Scaling up the trustworthy reuse of EHRs for clinical research
Presenter: KALRA, Dipak, The European Institute for Innovation through Health Data
Organisation: The European Institute for Innovation through Health Data
The delays and costs of conducting clinical trials are well recognised, largely due patient recruitment challenges. Routinely collected clinical data within electronic health records (EHRs) has the potential to enable protocols to be optimally designed to maximise eligible patient numbers, and to facilitate site selection and patient identification. The Electronic Health Records for Clinical Research project (EHR4CR) was funded through the Innovative Medicines Initiative to develop a scalable and societally acceptable approach to reusing hospital EHRs. It has successfully demonstrated the feasibility of a federated (distributed) platform architecture that can allow research sponsors to predict the patient numbers that meet proposed inclusion and exclusion criteria, permitting refinement of these criteria before a protocol is finalised. It can then support hospitals with identifying candidate patients to invite to participate. The platform is now being deployed by a commercial company that was a partner in EHR4CR, the set of connected hospitals is being expanded, and several pharma companies are starting to use the platform in an early adopter programme known as the Champion Programme.
This clinical research ecosystem of reusing EHR data requires governance in order to scale, in particular to ensure societal trust in the ways clinical data are handled. EHR4CR therefore established a not for profit organisation to define and promote good practices: the European Institute for Innovation through Health Data (i~HD). i~HD has developed several areas of trustworthy practice, and is promoting the adoption of these. It has also established a network of European hospitals wishing to accelerate their capability to reuse their EHR systems and data for research and for quality improvement: to become Learning Health Systems. i~HD is now starting to work proactively with patient organisations to help promote the value of clinical research more widely within society, to convey why reusing health data is so important.
Learning Objective 1: To understand the value of reusing EHRs for clinical research
Learning Objective 2: To understand how hospital EHRs can support better protocol design and patient recruitment
Learning Objective 3: To understand the importance of good practices in privacy protection