title: DEC-net: the development of the European register of clinical trials on medicines for children.
abstract: BACKGROUND
  The need to register a clinical trial in a public database has been widely discussed in the last few years. Several general clinical trial registers have been developed, but none are dedicated to children. A web-based register of trials on drug therapy in children was therefore developed.
  
  
  OBJECTIVE
  The general objective of the project, called DEC-NET (European register of clinical trials on medicines for children - drug evaluation in children) and supported by the European Community, is to provide the scientific community with a flexible tool for promoting communication and collaboration among researchers, disseminating clinical trial results and facilitating patient access and recruitment to trials.
  
  
  METHODS
  We identified a set of trial data to be collected, including general trial information, recruitment information, eligibility criteria, clinical trial characteristics, location and contact information, study drugs, study sponsor and results. The system was set up to allow authorized users (working in Italy, Spain, France and UK) to enter, handle and monitor the trial information. Medical data dictionaries (ie, ICD-9 and ATC) were used in order to make the data-entry and the search and data analysis procedures easier. A multilingual approach in data handling and presentation made accessing trial information in English and in the language of the country where the study is located feasible. Search and browsing tools were set up to allow investigators, researchers, and citizens to freely search and browse the entire register and access the details of trials meeting the search criteria.
  
  
  RESULTS
  The DEC-net register (http://www.dec-net.org) was opened for trial notification and consultation.
  
  
  CONCLUSIONS
  DEC-net currently involves four European countries and is a pilot project.
  
  
  CONCLUSIONS
  It is hoped that what has been achieved so far represents only the beginning of a long-term project, and the next step will be to extend the register's use to other European countries.
authors.affiliation: Laboratory of Medical Informatics, Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy. eugenio@marionegri.it
authors.forename: Eugenio
authors.initials: E
authors.lastname: Santoro
authors.forename: Valentina
authors.initials: V
authors.lastname: Rossi
authors.forename: Chiara
authors.initials: C
authors.lastname: Pandolfini
authors.forename: Maurizio
authors.initials: M
authors.lastname: Bonati
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic; D016208:Databases, Factual; D004358:Drug Therapy; D005060:Europe; D006801:Humans; D020407:Internet; D010865:Pilot Projects; D012042:Registries