Adverse event (AE) reporting systems for drugs and vaccines are required by the sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) for post market monitoring.
The official post-marketing safety surveillance program, Vaccine Adverse Event Reporting System (VAERS), and FDA Adverse Event Reporting System (FAERS) are programs to collect information regarding adverse events (AEs) that occur following the administration of drugs/vaccines licensed in the United States. Both VAERS and FAERS are supported by the Medical Dictionary for Regulatory Activities (MedDRA) as a controlled terminology system. MedDRA has disadvantages that include the lack of any definitions of AE terms and the poorly defined AE term relationships. A major limitation to this case reporting system is the requirement of coders to annotate the plain text description of various AE case reports and transfer AE text descriptions to MedDRA AE codes. The coders' work is time-consuming and inefficient. It would become very important if we can generate a tool to automatically assign AE codes from the users' case reports.
Ontae, a novel solution to the shortcomings of currently used terminology system
Ontae is an ontology-based VAE case reporting system that allows for accurate and easy case reporting and analysis of vaccine and drug AEs. The objective of Ontae is to improve current VAE case reporting and analysis system with a more efficient and effective ontology-based strategy. One key feature of our Ontae system is that the system allows different backgrounds of users, including professional clinicians and non-professional patients and patients' parents, to report the AEs with equal efficiency. Ontae will significantly change the paradigm of VAE case reporting and analysis strategy and will support advanced data integration and analysis, leading to better surveillance and understanding of vaccine-associated safety issues and internal mechanisms.
- Efficient web-based vaccine adverse event case reports
- Efficient web-based drug adverse event case reports
- Technology can be customized and used in other countries
- One key advantage is to remove the requirement of ‘coders’ who transfer plain AE text description to MedDRA codes, which will lead to big saving of cost.
- Web-based ontology customization and associated advanced Semantic Web technology to provide different backgrounds of users with different customized ontology subsets.
- Ontology-based algorithm to quickly identify comment AEs associated with particular vaccine/AEs and dynamically provides the AEs for users to choose.