A comprehensive analysis of paediatric Post-Authorization Studies (PAS) in the European Union has revealed significant insights into the landscape of drug research for children, highlighting both progress and areas needing improvement. The paper published on 11 December 2024 provides a detailed examination of paediatric studies registered between 2010 and 2023.

Of the 2,574 Post-Authorization Studies extracted from the EU PAS Registry, researchers examined 165 paediatric PAS, uncovering several critical trends:

1. Growing Research Interest: The annual number of paediatric PAS increased significantly from 2010 to 2023.

2. Study Characteristics:

• 86% of studies were observational

• 62% were funded by pharmaceutical companies

• Most focused on anti-infectives drugs (25%), nervous system medicines (18%), and antineoplastic agents (15%)

3. Age Group Coverage:

• 73.3% included children aged 2-11 years

• 61.8% involved infants and toddlers (from 28 days to 23 months)

• 57% encompassed adolescents (from 12 to 16/18 years)

• 43% included term newborns (from 0 to 27 days)

• 26% included preterm newborns

This analysis provides insight into the current state of paediatric pharmaceutical research, highlighting both progress and areas requiring further investigation. By raising awareness of existing gaps in the post-authorization phase, the study offers a valuable resource for industry and non-profit organizations to address unmet medical needs in paediatric medicine.

The study emphasizes the critical need for continued paediatric drug research. Children are often excluded from pre-authorization clinical trials due to ethical considerations, making PAS crucial for understanding long-term effects and appropriate dosages.

The researchers call for a more integrated approach to paediatric pharmaceutical research, including enhanced collaboration between industry and academia, increased regulatory guidance, prioritized research in areas with unmet therapeutic need, and greater transparency in study documentation.