Aggregation of Adverse Event Terms for Signal Detection and Labeling in Clinical Trials

Area of Science:

• Pharmacovigilance and Drug Safety
• Medical Terminology and Coding Systems
• Regulatory Science

Background:

• The Medical Dictionary for Regulatory Activities (MedDRA) was established to standardize adverse event coding.
• MedDRA is now the required dictionary for major regulatory authorities under the International Council for Harmonisation.
• Increasing terminology complexity necessitates methods for term aggregation.

Purpose of the Study:

• To present and discuss approaches for aggregating MedDRA preferred terms into meaningful medical concepts.
• To evaluate the pros and cons of different term grouping methods.
• To explore the feasibility of conducting analyses on aggregated terms versus preferred terms.

Main Methods:

• Review and synthesis of existing and proposed methods for aggregating MedDRA terms.
• Comparative analysis of term aggregation strategies.
• Illustrative examples of analyses using aggregated terms.

Main Results:

• Several approaches exist for aggregating MedDRA preferred terms into higher-level medical concepts.
• Analyses can be performed on aggregated terms, but specific features like severity require careful consideration.
• Aggregation aids in managing the growing volume of MedDRA terminology.

Conclusions:

• Aggregating MedDRA terms is essential for effective signal detection and labeling in pharmacovigilance.
• Careful consideration is needed for analyzing specific adverse event features at the aggregated level.
• New aggregation methods are vital for consistent and effective communication of drug safety information.