# The Development and Use of Office of New Drugs Custom Medical Queries for Safety Analyses of Clinical Trial Data

## TL;DR

The FDA developed custom medical queries to better detect safety signals in clinical trial data for drug approvals.

## Contribution

The FDA's Office of New Drugs created custom adverse event groupings to enhance safety signal detection in premarket drug evaluations.

## Key findings

- OND Custom Medical Queries improve detection of clinically meaningful safety signals.
- Custom groupings help distinguish and quantify adverse reactions in clinical trial data.
- The new queries provide better utility in premarket drug safety evaluations.

## Abstract

The evaluation of safety data by the US Food and Drug Administration (FDA) is a critical step in the review of marketing applications for drugs and biologics. It can be difficult to identify a safety signal, and important signals can be missed if not evaluated comprehensively. Adverse events reported by study participants constitute a major source of safety data, and while previously established standard term groupings have been useful for analysis (e.g., Standardised MedDRA® Queries), the Office of New Drugs (OND) at the FDA determined a need for more clinically meaningful groupings specifically designed for use in premarket drug safety evaluation. To improve safety signal detection and analyses of adverse reactions, OND developed standard groupings of adverse event terms known as OND Custom Medical Queries (OCMQs). OCMQs are intended to capture clinically meaningful groupings (i.e., safety signals) represented in premarketing data. OND has seen great utility in OCMQs during premarket drug safety evaluations, as they have improved OND’s ability to detect safety signals and to distinguish and quantify adverse reactions in clinical trial data.