Background The lack of drugs specifically designed and developed for paediatric population is a problem at European scale. Nowadays, over 50% of drugs prescribed to children have not been studied and, therefore, approved for this purpose. In 2006, the European Parliament promulgated a new regulation (No. 1901/2006)(1) to facilitate the development and availability of medicines for children.

Purpose The authors compiled an inventory of biomedical research in paediatrics (except oncologic trials) to describe paedriatric clinical trials characteristics in a French hospital and measure the impact of this regulation on clinical trials number and quality.

Materials and methods This study was conducted between November 2010 and May 2011 and the data collected from November 2002 to May 2011. On each trial file The authors collect: 1. The start date, design and sponsor of the study; 2. The population (number of inclusion, age and pathology); 3. Treatment (drugs and route of administration).

Results The authors reviewed 31 trials, which 11 are in progress (about 5% of all our studies). The industry sponsorised 25 of them and practically all were in phase 3. 18 (58%) started between 2002 and 2006 and 13 (42%) between 2007 and 2011. Only 5 (16%) studies were double-blind randomised (all started after 2006) and 14 (45%) failed to include patients. 144 children were included (84 in studies on milk and probiotics). The patients were aged between 1 day and 15 years (101 patients were old less than 30 days). Most of the trials concerned hormonal and endocrine pathologies (51%). No studies concerned new molecules or pharmaceutical forms adapted to the paediatric population.

Conclusions The regulations of 2006 had no impact on the number of clinical trials in our hospital. However, The authors observe an improvement of the quality of the studies. In addition to the small number of studies, The authors observe that many studies have difficulty to recruit. This difficulty could be connected to the exclusion and inclusion criteria, the rarity of the patients but also to the refusals of the parents.