Adverse Event Analysis and MedDRA: Business as Usual or Challenge?

Abstract

The Medical Dictionary for Regulatory Activities (MedDRA) is a dictionary of medical terms which covers signs and symptoms; diseases; diagnoses; therapeutic indications; names and qualitative results of indications; surgical and medical procedures; and medical, social, and family history. Until now, the pharmaceutical industry was only obligated to use MedDRA for submissions of individual case safety reports. Neither the MedDRA Maintenance and Support Services Organization nor regulatory bodies provided any recommendations on the use of MedDRA for analyses and reporting of clinical trial data. As the pharmaceutical industry introduces MedDRA in its day-to-day processes, there is an urgent need to fill this gap. The Biometry Subgroup of the German Association of Research-Based Pharmaceutical Companies has established a working group which will provide recommendations on the use of MedDRA in reporting and labeling. This paper aims to start a discussion about the use of MedDRA in the analysis of clinical trials.