MedDRA and Ontology Discussion of Strategy Barry Smith and Mélanie Courtot

Create an ontology directly by correcting MedDRA subsumption hierarchy Other cases such as Increased/decreased

Create an ontology directly by correcting MedDRA subsumption hierarchy Other cases such as Increased/decreased

Create an Ontology via Definitions Create formal definitions for some subset (module) of MedDRA terms using one or more of: AERO – Adverse Event Reporting Ontology OAE – Ontology of Adverse Events SNOMED Use a reasoner to create a corresponding MedDRA ontology module

Strategy for Definitions Add definitions to PTs Add relations such as location of the adverse event Have a reasoner classify the resulting ontology In each anatomical system group, check and add relations between PTs (e.g. abdominal pain lower is_a abdominal pain)

Examples from Adverse Event Reporting Ontology (AERO) Mélanie Courtot Simon Fraser University

Automate classification of adverse events Using a MedDRA- based mapping, I successfully encoded existing clinical guidelines for adverse events classification Anaphylaxis MedDRA (800 terms) --> Brighton guidelines --> Brighton ontology (32 terms) This is a strategy to create an ontology counterpart of one portion of MedDRA

Benefits of creating a MedDRA ontology Interoperability with other data resources drug surveillance EHR data Gene Ontology and related ontologies Currently SMQs built and maintained manually; the proposed ontology would allow us to build inclusion and exclusion criteria to create SMQs automatically, and also to update these SMQs automatically as MedDRA itself is changes -- saving time and effort (which could be quantified) It would provide also the ability to add multiple SMQs for the same AE, e.g. based on different guidelines Enhanced quality assurance Enhanced consistency checking

Data quality – ontology promotes assigning as early as possible in the pipeline; promote MedDRA as coding system to be used in the lab or clinic Secondary use: promotes using MedDRA data for research in the public domain for FDA different features are important than are important for clinical and translational science

Create Ontology to serve as Master MedDRA Using MedDRA Have MedDRA Ontology as core, with different views / linearizations of this core (ICD 11 model) for regulatory purposes for secondary uses for attaching term IDs for attaching English terms and terms and synonyms in other languages one target for maintenance with changes propagated through the whole structure