Proposed Terminology Changes to Facilitate the Analysis of MedDRA®-Coded Data

Abstract

This article is the continuation of a discussion about the utility of the Medical Dictionary for Regulatory Activities (MedDRA) in the analysis of adverse event data. This topic was initiated by the Biometry Subgroup of the German Association of Research-Based Pharmaceutical Companies. They pointed out issues within the MedDRA terminology that physicians and scientists are facing in safety and statistical analysis. These issues include multiaxiality in standard adverse event tabulation; lack of connection between laboratory results and disease/diagnosis, between patient social back-ground and disease classification; and more. Similar issues have been brought to the attention of the MedDRA Maintenance and Support Services Organization by MedDRA subscribers. In response to subscribers’ requests, the MedDRA Maintenance and Support Services Organization conducted a feasibility study on potential modifications to MedDRA’s hierarchy terms to better facilitate analytical requirements while considering the potential impacts of these changes on users of MedDRA. Changes to the MedDRA terminology were proposed and discussed.