AUTHOR=Bruno Raffaele 

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

JOURNAL=Frontiers in Veterinary Science

VOLUME=Volume 12 - 2025

YEAR=2025

URL=https://www.frontiersin.org/journals/veterinary-science/articles/10.3389/fvets.2025.1588068

DOI=10.3389/fvets.2025.1588068

ISSN=2297-1769

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.