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 providing functional interoperability profiles and supporting open source toolsets enabling EHR systems and clinical research systems to communicate and exchange EHR data; implementing semantic interoperability solutions enabling meaningful interpretation of the exchanged EHR data; implementing security and privacy mechanisms and open source toolsets ensuring that clinical information is shared in an ethical and safe way and providing a novel exploratory analysis framework for open-ended temporal pattern discovery for safety studies on top of disparate, distributed, heterogeneous EHR Systems.
SALUS
