Analysis of Paediatric Clinical Trial Characteristics and Activity Over 23 Years-Impact of the European Paediatric Regulation on a Single French Clinical Research Center

• Main Authors: Johanna Arnadottir (Author), François Luc (Author), Florentia Kaguelidou (Author), Evelyne Jacqz-Aigrain (Author), the Collaborative CIC1426 Investigator Group (Author), Auvin (Author), Delorme (Author), Vantalon (Author), Lecen (Author), eux (Author), Carel (Author), Tubiana (Author), Bismuth (Author), Baruchel (Author), Dalle (Author), Deschenes (Author), Hogan (Author), C. Dossier (Author), Kwon (Author), Faye (Author), Meinzer (Author), Melki (Author), Houdouin (Author), Munck (Author), Gerardin (Author), Hugot (Author), Vialla (Author), Biran (Author), Schmitz (Author), El Ghoneimi (Author), Dauger (Author), Bourat (Author), C. Alberti (Author), S. Guilmin Crepon (Author), O. Bourdon (Author)
• Format: Book
• Published: Frontiers Media S.A., 2022-04-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

As unlicensed or off-label drugs are frequently prescribed in children, the European Pediatric Regulation came into force in 2007 to improve the safe use of medicinal products in the pediatric population. This present report analyzes the pediatric research trials over 23 years in a clinical research...