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Descriptive Analysis of Pediatric Studies Included in the European Union Post-Authorization Study Register from 2010
Annalisa Landi1,2, Giorgio Reggiardo1,3, Antonella Didio2
1TEDDY European Network of Excellence for Pediatric Research, 27100 Pavia, Italy.
Insights
Pediatric Post-Authorization Studies (PASs) in the EU have increased, primarily observational and industry-funded. Research focuses on anti-infectives, nervous system, and cancer drugs, highlighting a need for more collaboration and targeted research.
Area of Science:
- Pharmacovigilance
- Pediatric Drug Safety
- Regulatory Science
Background:
- Post-Authorization Studies (PASs) are crucial for evaluating drug safety and efficacy after market approval.
- Pediatric populations often have unique responses to medications, necessitating specific safety monitoring.
- The European Union electronic Register of Post-Authorization Studies (EU PAS Register) is a key resource for tracking these studies.
Purpose of the Study:
- To analyze trends in pediatric PASs registered in the EU from 2010 to 2023.
- To identify patterns in study timing, age groups, and therapeutic areas.
- To examine funding sources and discuss pediatric-specific research considerations.
Main Methods:
- Screening of the EU PAS Register for studies exclusively on pediatric populations.
- Standardized data collection and descriptive analysis using univariate and multivariate linear regression.
- Assessment of trends over time and exploration of study characteristics.
Main Results:
- 165 pediatric PASs were analyzed, with a significant increase in annual numbers from 2010-2023.
- The majority were observational (86%) and used secondary data (53%).
- Pharmaceutical companies funded most studies (62%), with top therapeutic areas including anti-infectives, nervous system, and antineoplastic agents.
Conclusions:
- Post-marketing observational research in children has grown significantly.
- There is a need to encourage industry-academia collaboration in pediatric drug safety research.
- Regulatory guidance is essential to prioritize research in areas with unmet therapeutic needs for children.
Background/Objectives:
This work aimed to analyze pediatric Post-Authorization Studies (PASs) registered in the European Union electronic Register of Post-Authorization Studies (EU PAS Register) from September 2010 to April 2023 to identify trends in terms of timing, age groups, and therapeutic areas and to discuss pediatric specificities and sources of funding for the PASs.
Methods:
A screening process identified PASs conducted exclusively on the pediatric population, and instructions were provided to ensure standardized data collection from the EU PAS Register. A univariate linear regression descriptive analysis was performed to assess trends over time, while a multivariate linear regression analysis helped explore additional characteristics of these studies.
Results:
Of the 2574 PASs extracted from the EU PAS Registry, 165 were included in this analysis. The majority of pediatric PASs were observational studies (86%), and most of them utilized secondary data (53%). The annual number of PASs increased significantly between 2010 and 2023. As envisaged, the largest part was funded by pharmaceutical companies (62%). Anti-infectives for systemic uses (25%), medicines for the nervous system (18%), and antineoplastic and immunomodulating agents (15%) resulted in the most studied drugs.
Conclusions:
Our findings show that post-marketing observational research in pediatric populations has increased over time. Nevertheless, industry-academia collaboration should be encouraged, and regulatory guidance is needed to prioritize research in areas of unmet therapeutic need.
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