European Journal of Clinical Pharmacology

, Volume 64, Issue 6, pp 611–617

The DEC-net European register of paediatric drug therapy trials: contents and context

  • Chiara Pandolfini
  • Maurizio Bonati
  • Valentina Rossi
  • Eugenio Santoro
  • Imti Choonara
  • Coral Naylor
  • Helen Sammons
  • Evelyne Jacqz-Aigrain
  • Setareh Zarrabian
  • Josep Maria Arnau
  • Josep Maria Castel
  • Imma Danés
  • Inma Fuentes
Pharmacoepidemiology and Prescription

DOI: 10.1007/s00228-007-0458-2

Cite this article as:
Pandolfini, C., Bonati, M., Rossi, V. et al. Eur J Clin Pharmacol (2008) 64: 611. doi:10.1007/s00228-007-0458-2

Abstract

Objective

To describe the results and conclusions of DEC-net, an international, publicly available register of paediatric drug therapy clinical trials, and to assess which paediatric health areas are covered by research and by which trial types.

Methods

The contents of the register, which was set up by four groups (Italy, UK, France, Spain) who searched for paediatric trials and collected data between 2004–2006, were analysed. The disease areas reflected were compared with those covered by published trials and Burden of Disease (BD) data.

Results

In all, 257 trial records were analysed, 86 of which were entered by the Italian partner, 84 by the UK partner, 56 by the French partner and 31 by the Spanish partner. Spain entered the majority of multinational trials, while the UK had the majority of single-centre national trials. Most trials were experimental (79%), and the most commonly represented diseases were neoplasms (14% trials). In all, 28% were double-blind randomised controlled trials (RCTs). The most common disease areas addressed in the 257 trials were similar to the published trials’ areas. In contrast, the primary research area was low on the BD list.

Conclusions

DEC-net has demonstrated that international research efforts exist, even for paediatrics, although there may be an imbalance between national and multinational studies and a limited approach to double-blind RCTs. Recent initiatives will increase the number of children participating in research, and European legislation will require prospective registration. Paediatric research priorities must be better defined, however, and this can be done by registering research and making the information available to all relevant actors.

Keywords

Biomedical researchClinical trialsDrug therapyPediatricsRegistries

Copyright information

© Springer-Verlag 2008

Authors and Affiliations

  • Chiara Pandolfini
    • 1
  • Maurizio Bonati
    • 1
  • Valentina Rossi
    • 1
  • Eugenio Santoro
    • 2
  • Imti Choonara
    • 3
  • Coral Naylor
    • 3
  • Helen Sammons
    • 3
  • Evelyne Jacqz-Aigrain
    • 4
  • Setareh Zarrabian
    • 4
  • Josep Maria Arnau
    • 5
  • Josep Maria Castel
    • 5
  • Imma Danés
    • 5
  • Inma Fuentes
    • 5
  1. 1.Laboratory for Mother and Child Health“Mario Negri” Pharmacological Research InstituteMilanItaly
  2. 2.Laboratory of Medical Informatics“Mario Negri” Pharmacological Research InstituteMilanItaly
  3. 3.Academic Division of Child Health, University of Nottingham Derbyshire Children’s HospitalDerbyUK
  4. 4.Pharmacology, Hôpital Robert DebréParisFrance
  5. 5.Fundació Institut Català de FarmacologiaBarcelonaSpain