Affiliations: Consorzio per Valutazioni Biologiche e Farmacologiche,
Pavia, Italy | Azienda Ospedaliera di Padova, Padova, Italy | Leiden/Amsterdam Center for Drug Research, Leiden, The
Netherlands | Medical Research Council, London, UK | Charité Universitätsmedizin Berlin, Berlin,
Germany
Note: [] Corresponding author: Adriana Ceci, Consorzio per Valutazioni
Biologiche e Farmacologiche, Via Palestro 26, 27100 Pavia, Italy. Tel.: +39
0382 25075; Fax: +39 0382 536544; E-mail: [email protected]
Abstract: For years the lack of studies specifically designed to investigate
pharmacological and toxicological aspects in the paediatric population has
forced children to use many approved drugs without a proper information on
dosage, efficacy and safety and on the basis of data extrapolated from adults
studies. In Europe, the Directive EC/2001/20 on Good Clinical Practice, was
the first to take into consideration the need of performing clinical trials in
children in compliance with the current GCP requirements. Moreover, the Note
for Guidance ICH Topic E11 gives recommendations on clinical trials'
characteristics. Our study found that under the EMEA centralised procedure, 60 drugs
were licensed for use in children in the period 1995–2005. These data show an
increasing trend in the percentage of EMEA approved medicines for children
compared with previously reported figures. Moreover, few clinical studies were performed in compliance with the
paediatric age groups as defined by the ICH/E11 guideline. This is of
particular concern especially when the adolescent age group is considered,
since adolescents are frequently recruited together with adults. The new Paediatric Regulation, in force from January 2007, is
expected to dramatically change this situation.
Keywords: TEDDY, clinical trial methodology, paediatric medicines, Europe
