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Acta Paediatr. 2008 Sep;97(9):1232-7. doi: 10.1111/j.1651-2227.2008.00878.x. Epub 2008 May 13.

European paediatric research and children's therapeutic needs. A trial review.

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Laboratory for Mother and Child Health, Mario Negri Pharmacological Research Institute, Milan, Italy.



To evaluate the current paediatric therapeutic research situation in Europe with respect to paediatric needs and drug therapies.


Data from ongoing and published paediatric drug therapy trials from 2004 to 2007 were evaluated and compared to the European Medicines Agency (EMEA) priority list for studies on paediatric medicinal products. Ongoing trial data from the DEC-net paediatric trial register and published trials from two biomedical databases were used.


In all, 379 trials from the 27 European Union (EU) countries were found (most common country: Italy, 18.2%). The major disease area covered was 'infectious and parasitic diseases' (21.4%). Only four of 25 EMEA priority conditions were addressed, the most common were 'malignant diseases' (18.2% of trials) and 'asthma' (3.2%). A subset of 190 published trials, representing the same four countries that participated in DEC-net (France, Italy, Spain and United Kingdom), was compared to the register's 257 ongoing trials. Some significant differences in disease areas covered were found. Concerning the EMEA priority conditions, the ongoing research addressed more of them.


Paediatric research is being carried out in Europe, but this study found a general lack of overlap between therapeutic needs and research. The Paediatric Regulation will hopefully lead to research that is more focused on children's needs.

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