![]() In particular, this document provides suggested guidance on the general principles of harmonisation between regulatory and strategic trials, including (1) standardised key inclusion/exclusion criteria and widely applicable outcome measures for specific clinical infectious syndromes (CIS) to be used in CTs on efficacy of antibiotic in children (2) key components of safety that should be reported in paediatric antibiotic CTs (3) standardised sample sizes for safety studies. The suggestions being put forward here are based on the adult EMA guidance, adapted for neonates and children. The evidence base for any specific criteria for the design and conduct of efficacy and safety antibiotic trials for children is very limited and will evolve over time as further studies are conducted. The board of the European networks for paediatric research at the European Medicines Agency (EMA), in collaboration with the Paediatric European Network for Treatments of AIDS-Infectious Diseases network (recently developed a Working Group on paediatric antibiotic CT design, involving academic, regulatory and industry representatives. There is currently considerable heterogeneity in the design and conduct of paediatric antibiotic studies, hampering comparison and meta-analytic approaches. 12 Institute of Translational Medicine, Centre for Women's Health Research, Liverpool Women's Hospital, Crown Street, Liverpool, UK.Īntimicrobial development for children remains challenging due to multiple barriers to conducting randomised clinical trials (CTs).11 Department of Woman's and Child's Health, University of Padova, Padua, Italy.10 AstraZeneca, 950 Wind River Ln, Gaithersburg, MD, USA.9 Division of Infectious Diseases and the Center for Pediatric Clinical Effectiveness, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.8 Infectious Diseases Unit, 3rd Department of Paediatrics, Faculty of Medicine, Aristotle University 96 School of Health Sciences, Thessaloniki, Greece.7 MRC Clinical Trials Unit at UCL, Institute of Clinical Trials Methodology, UCL, London, UK.6 Nuffield Department of Clinical Medicine NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK.5 Great Ormond Street Institute of Child Health, University College London, London, UK.4 Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George's University of London, London, UK.3 Department of Microbiology, Faculty of Medicine, University of Tartu, Tartu, Estonia.1 Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George's University of London, London, UK 2 Paediatric Infectious Disease Unit, Department of Paediatrics, Luigi Sacco Hospital, University of Milan, Milan, Italy.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |