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

  • Pharmacoepidemiology and Prescription
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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.

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Acknowledgements

The DEC-net project was funded by the European Union’s Fifth Framework Programme, Thematic Programme “Quality of Life” (contract QLG4-CT-2002-01054). Chiara Pandolfini’s work was funded by a Monzino Fellowship. The authors wish to thank Dr. Rossella Rossi and Dr. Ines Lorenzi, from Genoa’s Gaslini Hospital’s ethics committee for support in data correction, and Joel Steingo, from the Derbyshire Children’s Hospital, University of Nottingham, for his important role in the project’s start-up early on.

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Authors and Affiliations

  1. Laboratory for Mother and Child Health, “Mario Negri” Pharmacological Research Institute, Via G. La Masa 19, 20156, Milan, Italy

    Chiara Pandolfini, Maurizio Bonati & Valentina Rossi

  2. Laboratory of Medical Informatics, “Mario Negri” Pharmacological Research Institute, Via G. La Masa 19, 20156, Milan, Italy

    Eugenio Santoro

  3. Academic Division of Child Health, University of Nottingham, Derbyshire Children’s Hospital, Clinical Sciences Building, Uttoxeter Road, DE22 3DT, Derby, UK

    Imti Choonara, Coral Naylor & Helen Sammons

  4. Pharmacology, Hôpital Robert Debré, Boulevard Serurier 48, 75019, Paris, France

    Evelyne Jacqz-Aigrain & Setareh Zarrabian

  5. Fundació Institut Català de Farmacologia, Passeig Vall D’Hebron 119-129, 08035, Barcelona, Spain

    Josep Maria Arnau, Josep Maria Castel, Imma Danés & Inma Fuentes

Authors
  1. Chiara Pandolfini
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  2. Maurizio Bonati
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  3. Valentina Rossi
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  4. Eugenio Santoro
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  5. Imti Choonara
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  6. Coral Naylor
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  7. Helen Sammons
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  8. Evelyne Jacqz-Aigrain
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  9. Setareh Zarrabian
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  10. Josep Maria Arnau
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  11. Josep Maria Castel
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  12. Imma Danés
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  13. Inma Fuentes
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Corresponding author

Correspondence to Chiara Pandolfini.

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Pandolfini, C., Bonati, M., Rossi, V. et al. The DEC-net European register of paediatric drug therapy trials: contents and context. Eur J Clin Pharmacol 64, 611–617 (2008). https://doi.org/10.1007/s00228-007-0458-2

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  • DOI: https://doi.org/10.1007/s00228-007-0458-2

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