Brief Project Overview

Pre-approval clinical trials cannot guarantee that drugs will not have serious side effects after they are marketed. Post-approval drug safety data studies aim to address this problem; however, their effectiveness is started to be discussed especially after recent examples of drug withdrawals. This is due to the fact that, current post market safety studies largely depend on the submission of spontaneous case reports where underreporting is a major problem.  The need for a more proactive approach is apparent, where safety data from multiple sources are actively monitored, linked and analyzed. Effective integration and utilization of electronic health records (EHR) can help to improve post-market safety activities on a proactive basis. SALUS aims to facilitate this through the following subtasks:

 

  • Providing functional interoperability profiles and supporting open source toolsets enabling EHR systems and clinical research systems to communicate and exchange EHR data for post market safety studies through a common transport protocol
  • Providing Semantic Interoperability Framework enabling meaningful interpretation of the exchanged EHR data, through:
  • Development of a core set of common data elements for post market safety studies. This will be facilitated by identifying the information requirements for the selected proactive post market safety use cases, selecting and adapting the already existing data sets in clinical research and care domains, and formally representing them as the common SALUS ontology by also interlinking them with the available domain ontologies and terminologies
  • Developing Semantic Mediation Mechanism for proactive post market safety studies on top of the SALUS harmonized ontology
  • Providing security and privacy mechanisms and open source toolsets (such as authentication, authorization, pseudonymization and accountability through audits) ensuring that clinical information is shared in an ethical and safe way, complying with all necessary legal requirements designed to protect patient rights and interests
  • Developing novel exploratory analysis framework for open-ended temporal pattern discovery for safety studies on top of the electronic health records collected from disparate, distributed, heterogeneous EHR systems
  • Implementation of high potential use cases enabling secondary use of EHRs such as ADE monitoring/reporting, exploratory signal detection studies over multiple distributed EHRs, wide scale observational studies for epidemiology and outcome research