David Moner, Clinical Trials Powered by Electronic Health Records
David Moner of Universitat Politecnica de Valencia was first to present during the Electronic Health Record (EHR) session on the second day of the European Interchange. Mr. Moner began his presentation by summarizing the current status of EHR use in the healthcare industry; he detailed that, while a great deal of effort and investment has been put toward the adoption of EHR systems, and although this has benefitted healthcare delivery, so far it has not been as clearly beneficial for clinical research. Specifically, the concept of EHR data reuse remains an unresolved issue. Read More.
Kiyoteru Takenouchi, Japanese Sentinel and MIHARI Project
Kiyoteru Takenouchi of CMIC was next introduced, and began his discussion by describing how the EHR is currently in use in Japan. At this time, 90% of large hospitals in Japan have Computerized Physician’s Order Entry (CPOE). The PMDA’s (Japan’s FDA) MIHARI Project focuses on having four working groups for each information source: 1) reimbursement claims and Diagnosis Procedure Combination (DPC)/Diagnosis Related Group (DRG), 2) hospital information system, 3) spontaneous adverse events reported to PMDA, and 4) post market surveillance collected by pharmaceutical companies. Data is changed to a standard format when it is sent to storage, which allows reuse for many purposes, such as referrals to other clinics and hospitals. Read More.
Pierre-Yves Lastic, Report from the EHR4CR Project
Pierre-Yves Lastic of Sanofi Aventis followed Mr. Takenouchi, and presented on the Innovative Medicine Initiative’s (IMI) EHR4CR Project, a four-year project (2011-14) with a budget of over 16M euros with the objective of promoting the wide-scale reuse of EHR data to accelerate regulated clinical trials across Europe (although now that the FDA is a part of the advisory committee this is anticipated to expand). The project works with 10 pharmaceutical companies, 22 public partners from academia, hospitals and SMEs (including CDISC), and five subcontractors. To date, this project is one of the largest public-private partnerships working on reuse of EHR data for clinical research. Reuse of EHR data offers opportunities to advance medical research, improve healthcare and enhance patient safety.