Can we get the necessary clinical trials in children and avoid the unnecessary ones?
- Kalle Hoppu
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Clinical trials are necessary to provide data on the safety, efficacy and optimal use of medicines. In children, data are needed to cover all ages, from newborns to adolescents. Getting the necessary clinical trials performed is required to achieve the goals of the U.S., EU and WHO paediatric medicines initiatives . However, as stated in the EU Paediatric Regulation , unnecessary trials should be avoided for obvious ethical reasons.
For new medicinal products of therapeutic interest for children, the EU requirement of early submission of a Paediatric Investigation Plan (PIP) for approval by the Paediatric Committee (PDCO), and compliance with the PIP to get the substantial reward/incentive are likely to capture most of the necessary trials being  performed. So far the majority of the 122 PIPs approved by the PDCO  include a deferral for the studies to be performed after more data become available in adults. However, it is already evident that clinical trials of off-patent pr ...
- Hoppu, K (2008) Paediatric clinical pharmacology-at the beginning of a new era. Eur J Clin Pharmacol 64: pp. 201-5 CrossRef
- EC (2006) Regulation (EC) no 1901/2006 of the European Parliament and of the Council on Medicinal Products for Paediatric Use and amending Regulation (EEC) no 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) no 726/2004, EC/190
- EMEA (2009) Press release from the PDCO March meeting. http://www.emea.europa.eu/pdfs/human/pdco/11830509en.pdf. Accessed 13 March 2009
- Tafuri, G, Trotta, F, Leufkens, HG, Martini, N, Sagliocca, L, Traversa, G (2009) Off-label use of medicines in children: can available evidence avoid useless paediatric trials? The case of proton pump inhibitors for the treatment of gastroesophageal reflux disease. Eur J Clin Pharmacol 65: pp. 209-16 CrossRef
- Anonymous (2004) Editorial: depressing research. Lancet 363(9418):1335
- Hill, S, Regondi, I, Grzemska, M, Matiru, R (2008) Children and tuberculosis medicines: bridging the research gap. Bull World Health Org 86: pp. 658 CrossRef
- de Wildt S, Knibbe C. Knowledge of developmental pharmacology and modeling approaches should be used to avoid useless trials in children. Eur J Clin Pharmacol. doi:10.1007/s00228-009-0655-2
- Can we get the necessary clinical trials in children and avoid the unnecessary ones?
European Journal of Clinical Pharmacology
Volume 65, Issue 8 , pp 747-748
- Cover Date
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- Clinical trials
- Drug evaluation
- Clinical pharmacology
- Industry Sectors
- Kalle Hoppu (1) (2)
- Author Affiliations
- 1. Poison Information Centre, Helsinki University Central Hospital, P.O. Box 790, Tukholmankatu 17, 00029, HUS, Helsinki, Finland
- 2. Hospital for Children and Adolescents and Dept. of Clinical Pharmacology, University of Helsinki, Helsinki, Finland