DEC-NET: the European register of clinical trials on medicines for children

Article type
Authors
Santoro E, Rossi V, Pandolfini C, Bonati M
Abstract
Background: Bibliographic databases such as Medline and the Cochrane Library are accepted worldwide as the best way to obtain reliable data on clinical trials. However, paediatric trials are often stopped prematurely and do not end up being published in peer reviewed journals.

Objectives: We have developed a web-based register of trials on drug therapy in children in order to provide one way of overcoming these issues. The general objective of this project, named DEC-NET (European register of clinical trials on medicines for children – Drug Evaluation in Children) and supported by the European Community, is to provide scientific community with a flexible tool for disseminating clinical trial results, promoting collaboration among researchers, and preventing trial duplication and inappropriate funding.

Methods: We have collected many trial data including the trial name, the eligibility criteria, the trial status, the drug(s) tested, the summary, the main results, the sponsor, the contact details, and the main references. Medical data dictionaries (such as ICD-9 and ATC) were used in order to make the data-entry and the search and data analysis procedures easier. Data were provided by the European project partners through a web based system.

Results: The register is available on the web at http://www.dec-net.org. It is based on two separate modules. The administrative module allows authorised users (working in Italy, Spain, France and UK) to enter and handle the trial information. The searching module allows investigators, researchers, and citizens to freely search the register and access the details (in English and in the original language) of those trials meeting the search criteria.
The data collection started in July 2004 and the register is open for trial notification and consultation. At present more than 100 planned or ongoing trials are available in the register and in the next months we expect to include most of the clinical trials in pediatrics conducted in the 4 country partners.
Conclusions: As of today, DEC-NET is the first and unique register of clinical trials in pediatrics available on the web. At the end of project (December 2005) we would like to open the register to include trials from other countries.