Affiliations: Consorzio per Valutazioni Biologiche e Farmacologiche,
Pavia, Italy | Department of Mother and Child, University of Modena
and Reggio Emilia, Modena, Italy | University College London, London, UK | Pharmacoepidemiology Unit, Departments of Medical
Informatics and Epidemiology & Biostatistics, Erasmus University Medical
Center, Rotterdam, The Netherlands | Department of Paediatrics, Hospital Carlos III,
Madrid, Spain | Charité Universitätsmedizin Berlin, Berlin,
Germany | Department of Clinical Pharmacology, San Antonio
Hospital, Niewegein, The Netherlands
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: One of TEDDY objectives is to "to identify unmet therapeutic needs
for the development and use of medicinal products in male/female children" and
it is compliant with the new provisions established by the Paediatric
Regulation. Thus TEDDY set up 12 Therapeutic Experts Groups (TEGs) to identify
the needs in some therapeutic areas of paediatric interest. Starting from the Assessment Documents released by EMEA-PEG and
later on by EMEA-PDCO, a total of 14 therapeutic areas were analysed. TEDDY experts have identified 442 products that need to be
specifically developed for children by either extending the current authorised
indication or developing new indications. Moreover, the study shows that a
total of 1480 studies (i.e. PK, dosage, efficacy, safety or long term safety)
should be conducted in order to develop more drugs for children. In the light of these results, it is reasonable to question if all
these studies are absolutely necessary and consequently if there are enough
children to be enrolled in the trials for the same therapeutic area. It is imperative to adopt a procedure of selecting which drugs need
to be developed for each therapeutic area in order to avoid repetitive and
unnecessary trials in children.
Keywords: TEDDY, children, drug development, therapeutic needs, priority lists
