Descriptive Analysis of Pediatric Studies Included in the European Union Post-Authorization Study Register from 2010 to 2023
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 area...
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MDPI AG
2025-02-01
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| Series: | Pediatric Reports |
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| Online Access: | https://www.mdpi.com/2036-7503/17/1/24 |
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| author | Annalisa Landi Giorgio Reggiardo Antonella Didio Annunziata D’Ercole Adriana Ceci Grace Shalom Govere Donato Bonifazi Fedele Bonifazi Salvatore Crisafulli Gianluca Trifirò Florentia Kaguelidou Katja Marja Hakkarainen Katarina Gvozdanović Francesco Barone-Adesi Andrealuna Ucciero Mariagrazia Felisi |
| author_facet | Annalisa Landi Giorgio Reggiardo Antonella Didio Annunziata D’Ercole Adriana Ceci Grace Shalom Govere Donato Bonifazi Fedele Bonifazi Salvatore Crisafulli Gianluca Trifirò Florentia Kaguelidou Katja Marja Hakkarainen Katarina Gvozdanović Francesco Barone-Adesi Andrealuna Ucciero Mariagrazia Felisi |
| author_sort | Annalisa Landi |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-9f6e88463f6948faa9e6e8c75f70a81d |
| institution | DOAJ |
| issn | 2036-7503 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pediatric Reports |
| spelling | doaj-art-9f6e88463f6948faa9e6e8c75f70a81d2025-08-20T02:44:32ZengMDPI AGPediatric Reports2036-75032025-02-011712410.3390/pediatric17010024Descriptive Analysis of Pediatric Studies Included in the European Union Post-Authorization Study Register from 2010 to 2023Annalisa Landi0Giorgio Reggiardo1Antonella Didio2Annunziata D’Ercole3Adriana Ceci4Grace Shalom Govere5Donato Bonifazi6Fedele Bonifazi7Salvatore Crisafulli8Gianluca Trifirò9Florentia Kaguelidou10Katja Marja Hakkarainen11Katarina Gvozdanović12Francesco Barone-Adesi13Andrealuna Ucciero14Mariagrazia Felisi15TEDDY European Network of Excellence for Pediatric Research, 27100 Pavia, ItalyTEDDY European Network of Excellence for Pediatric Research, 27100 Pavia, ItalyFondazione per la Ricerca Farmacologica Gianni Benzi Onlus, 70124 Bari, ItalyFondazione per la Ricerca Farmacologica Gianni Benzi Onlus, 70124 Bari, ItalyTEDDY European Network of Excellence for Pediatric Research, 27100 Pavia, ItalyCVBF–Consorzio per Valutazioni Biologiche e Farmacologiche, 70122 Bari, ItalyTEDDY European Network of Excellence for Pediatric Research, 27100 Pavia, ItalyTEDDY European Network of Excellence for Pediatric Research, 27100 Pavia, ItalyDepartment of Diagnostics and Public Health, University of Verona, 37134 Verona, ItalyDepartment of Diagnostics and Public Health, University of Verona, 37134 Verona, ItalyAssistance Publique–Hôpitaux de Paris, Hôpital Universitaire Robert-Debré Centre d’Investigations Cliniques et d’Epidémiologie Clinique, 75019 Paris, FranceParexel International, Epidemiology and Real-World Evidence, 41123 Gothenburg, SwedenPharmacoepidemiology Department, Teaching Institute of Public Health “Dr. Andrija Stampar”, Zagreb 10 000, CroatiaDepartment of Translational Medicine, University of Eastern Piedmont, 28100 Novara, ItalyHospital Pharmacy, University Hospital Maggiore della Carità, 28100 Novara, ItalyTEDDY European Network of Excellence for Pediatric Research, 27100 Pavia, ItalyBackground/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.https://www.mdpi.com/2036-7503/17/1/24Post-Authorization StudiespediatricEU PAS Registerdescriptive analysis |
| spellingShingle | Annalisa Landi Giorgio Reggiardo Antonella Didio Annunziata D’Ercole Adriana Ceci Grace Shalom Govere Donato Bonifazi Fedele Bonifazi Salvatore Crisafulli Gianluca Trifirò Florentia Kaguelidou Katja Marja Hakkarainen Katarina Gvozdanović Francesco Barone-Adesi Andrealuna Ucciero Mariagrazia Felisi Descriptive Analysis of Pediatric Studies Included in the European Union Post-Authorization Study Register from 2010 to 2023 Pediatric Reports Post-Authorization Studies pediatric EU PAS Register descriptive analysis |
| title | Descriptive Analysis of Pediatric Studies Included in the European Union Post-Authorization Study Register from 2010 to 2023 |
| title_full | Descriptive Analysis of Pediatric Studies Included in the European Union Post-Authorization Study Register from 2010 to 2023 |
| title_fullStr | Descriptive Analysis of Pediatric Studies Included in the European Union Post-Authorization Study Register from 2010 to 2023 |
| title_full_unstemmed | Descriptive Analysis of Pediatric Studies Included in the European Union Post-Authorization Study Register from 2010 to 2023 |
| title_short | Descriptive Analysis of Pediatric Studies Included in the European Union Post-Authorization Study Register from 2010 to 2023 |
| title_sort | descriptive analysis of pediatric studies included in the european union post authorization study register from 2010 to 2023 |
| topic | Post-Authorization Studies pediatric EU PAS Register descriptive analysis |
| url | https://www.mdpi.com/2036-7503/17/1/24 |
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