T-07: FDA Developed Tool for Adverse Event Data Signal Detection in Clinical Safety Analysis

Poster Presenter

Xin Li

Mathematic Statistician, Office of Translational Science, CDER
FDA
United States

Objectives

The FDA developed MAED (MedDRA-based Adverse Event Diagnostics) tool is an adverse event (AE) analysis tool

Method

The MAED tool enables reviewers to perform important safety analyses on all levels of the MedDRA hierarchy, as well as perform analyses using Standard MedDRA Queries (SMQs).

Results

MAED enables reviewers to quickly generate a large number of adverse event analyses on both pre-market clinical trial data and post-market AE data.

Conclusion

MAED analysis functionality significantly broadens reviewers’ ability to quickly and effectively conduct safety signal detection assessments and provide adverse event analysis capabilities that are otherwise not available to reviewers.