We are excited to announce a new publication on paediatric post-authorization studies (PASs). The study, authored by Annalisa Landi, Antonella Didio, Annunziata D’Ercole, Adriana Ceci, and Fedele Bonifazi is now available in MDPI Pediatric Reports.

PASs play a crucial role in the post-authorization phase of a drug. They help confirming the benefit–risk profile of drugs in real-world settings and detecting long-term or rare adverse events that may not have been identified in pre-authorization clinical trials. However, to date, no studies have analysed the characteristics and described the impact of paediatric PASs. This study aimed to cover this gap by analysing paediatric PASs included in the European Union Post-Authorization Study Register (EU PAS Register) from 2010 to 2023.
The study explores trends in terms of timing, therapeutic areas, age groups, and funding sources. It identifies key patterns and challenges in paediatric post-marketing surveillance. Additionally, it highlights gaps in research and areas requiring further attention.
Results describe how paediatric PASs are distributed across different therapeutic areas and age categories. The study also provides insights into funding sources, revealing the leading role of industry.  The results of the statistical analysis were also shown.
Overall, this research underlines the need for more tailored PASs in paediatrics. Raising awareness of current gaps can help prioritize research in areas of unmet therapeutic need. More importantly, it highlights the need for a regulatory guidance and for industry–academia collaboration.

To view the full publication, visit MDPI Pediatric Reports here.