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Neonatal drug trials: impact of EU and US paediatric regulations
  1. Claudia Pansieri1,2,
  2. Maurizio Bonati2,
  3. Imti Choonara3,
  4. Evelyne Jacqz-Aigrain1,4,5
  1. 1Service de Pharmacologie Pédiatrique, AP-HP, Hôpital Robert Debré, Paris, France
  2. 2Laboratory for Mother and Child Health, Department of Public Health, IRCCS Istituto di Ricerche Farmacologiche ‘Mario Negri’, Milan, Italy
  3. 3Academic Division of Child Health, Derbyshire Children's Hospital, University of Nottingham, Derby, UK
  4. 4Université Paris Diderot, Sorbonne Paris Cité, Paris, France
  5. 5INSERM, CIC1426, Hôpital Robert Debré, Paris, France
  1. Correspondence to Professor Evelyne Jacqz-Aigrain, Department of Paediatric Pharmacology and Pharmacogénétics, Hôpital Robert Debré, 48 boulevard Serurier, Paris 75019, France; evelyne.jacqz-aigrain{at}rdb.aphp.fr

https://doi.org/10.1136/archdischild-2013-305900

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    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 …

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    Footnotes

    • Contributors CP retrieved data, carried out the initial analyses, drafted the initial manuscript, reviewed and revised the manuscript, and approved the final manuscript as submitted. MB supervised the retrieving of the data and performed analyses, reviewed and revised the manuscript, and approved the final manuscript as submitted. IC critically reviewed and revised the manuscript, and approved the final manuscript as submitted. EJ-A conceptualised, designed and initiated the study, reviewed and revised the manuscript, and approved the final manuscript as submitted.

    • Funding This work is part of: the TINN network (Collaborative Project), supported by the European Commission under the Health Cooperation Work Programme of the 7th Framework Programme (grant agreement no. 223614) and the GRIP network (Network of Excellence (GRiP), supported by the European Commission under the Health Cooperation Work Programme of the 7th Framework Programme (Grant Agreement no 261060).

    • Competing interests None.

    • Provenance and peer review Not commissioned; externally peer reviewed.