Abstract
Over the past decades, drugs have been used in children at different ages, outside the terms of their marketing authorizations in relation to indication, dosage, age, and route of administration, both in Europe and worldwide. The off-label use of drugs exposes children to unexpected adverse reactions or to suboptimal treatment. To develop safe medicines for children, ensuring that pediatric medicines are of high quality, ethically researched, and authorized appropriately, many legislative efforts have been made at European and international level. This chapter will address specific regulatory and ethical aspects included in legal frameworks and ethical guidelines.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Similar content being viewed by others
References
Altavilla A, Manfredi C, Baiardi P, Dehlinger-Kremer M, Galletti P, Chaplin J, Ceci A. Impact of the new european paediatric regulatory framework on ethics committees: overview and perspectives. Acta Paediatr. 2012;101(1):27–32.
Altavilla A, Giaquinto C, Ceci A. Activity of Ethics Committees in Europe on issues related to clinical trials in paediatrics: results of a survey. Pharm Policy Law. 2009; 11: 1–9
Altavilla A, Giaquinto C, Ceci A. European survey on ethical and legal framework of clinical trials in paediatrics: results and perspective. J Int Bioethique. 2008;19(3):17–48.
Baiardi P, Giaquinto C, Girotto S, Manfredi C, Ceci A. Eur J Clin Pharmacol. 2011; 67 (11 suppl): 1–133. Especially: Altavilla A. Ethical key issues and fundamental rights in paediatric research. pp 1–7
Coleman CH. Vulnerability as a regulatory category in human subject research. J Law Med Ethics. 2009;31(1):12–8. Spring.
European Commission. Ethical considerations for clinical trials on medicinal products with the paediatric population. Eudralex, vol 10. 2008
Friedman Ross L. Children in medical research. New York: Oxford University Press; 2006. 285 p.
ICH (E11), Clinical investigation of medicinal products in the paediatric population, CPMP/ICH/2711/99
Pinxten W, Nys H, Dierickx K. Frontline ethical issues in pediatric clinical research: ethical and regulatory aspects of seven current bottlenecks in pediatric clinical research. Eur J Pediatr. 2010;169(12):1541–8.
Further Reading
Knellwolf AL, Bauzon S, Alberighi OD, Lutsar I, Bácsy E, Alfarez D, Panei P. Framework conditions facilitating paediatric clinical research. Ital J Pediatr. 2011;37:12.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2013 Springer-Verlag Berlin Heidelberg
About this entry
Cite this entry
Altavilla, A. (2013). Pediatric Clinical Trials. In: Beran, R. (eds) Legal and Forensic Medicine. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-32338-6_105
Download citation
DOI: https://doi.org/10.1007/978-3-642-32338-6_105
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-642-32337-9
Online ISBN: 978-3-642-32338-6
eBook Packages: Biomedical and Life SciencesReference Module Biomedical and Life Sciences