The DEC-net European register of paediatric drug therapy trials: contents and context.
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.
Pandolfini
Chiara
C
Laboratory for Mother and Child Health, Mario Negri Pharmacological Research Institute, Via G. La Masa 19, 20156 Milan, Italy. pandolfini@marionegri.it
Bonati
Maurizio
M
Rossi
Valentina
V
Santoro
Eugenio
E
Choonara
Imti
I
Naylor
Coral
C
Sammons
Helen
H
Jacqz-Aigrain
Evelyne
E
Zarrabian
Setareh
S
Arnau
Josep Maria
JM
Castel
Josep Maria
JM
Danés
Imma
I
Fuentes
Inma
I
D002648:Child; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D004358:Drug Therapy / Q000706:statistics & numerical data*; D005060:Europe; D006801:Humans; D012042:Registries