# Use of real-world data as pivotal evidence in veterinary regulatory applications

## TL;DR

This paper explores how real-world data can be used in veterinary medicine to support drug approvals, similar to its use in human medicine.

## Contribution

The paper highlights the potential of real-world data in veterinary regulatory applications despite current limitations.

## Key findings

- Real-world data can complement or replace randomized clinical trials in veterinary medicine.
- Challenges include data quality, methodological rigor, and regulatory acceptance.
- Reflections on RWD applications in veterinary medicine are already feasible.

## Abstract

Real-world data (RWD) has the potential to complement or serve as an alternative to randomized clinical trials (RCTs) in veterinary medicine, mirroring trends observed in human medicine. Sourced from diverse platforms including digital databases and wearable devices, RWD may provide valuable insights into the effectiveness, safety, and broader societal impacts of veterinary medicinal products. Although its role as pivotal evidence in veterinary drug submissions remains limited due to challenges related to data quality, methodological rigor, and regulatory acceptance, reflections on its potential applications in the veterinary domain are already possible.