TY - JOUR T1 - Neonatal drug trials: impact of EU and US paediatric regulations JF - Archives of Disease in Childhood - Fetal and Neonatal Edition JO - Arch Dis Child Fetal Neonatal Ed SP - F438 LP - F438 DO - 10.1136/archdischild-2013-305900 VL - 99 IS - 5 AU - Claudia Pansieri AU - Maurizio Bonati AU - Imti Choonara AU - Evelyne Jacqz-Aigrain Y1 - 2014/09/01 UR - http://fn.bmj.com/content/99/5/F438.abstract N2 - The rational use of medicines in neonates is limited by the lack of scientific evidence for their use, as most medicines used in neonates are either unlicensed or off-label.1 In order to improve this situation, legislation has been passed in Europe and the USA to encourage the pharmaceutical industry to study medicines in the paediatric and neonatal populations. In order to evaluate the impact of these paediatric regulations in the neonatal population, we analysed the drug trials registered in the Clinicaltrials.gov database.Among all (138 948) trials registered, 30 912 (22%) were paediatric trials, and only 288 (0.2%) involved neonates. The number of trials registered grew steadily over time. From 1999 to 2012 trials … ER -