DEC-NET: The first european register of clinical trials in children

Introduction: Registering clinical trials in public registers before they start may prevent publication bias, promote collaboration among research groups, inform the public, and increase dissemination of results. None of the numerous existing registers are dedicated specifically to children. A web-based register of trials on drug therapy in children named DEC-net (The European register of clinical trials on medicines for children -Drug Evaluation in Children) was therefore developed by a network of four groups from Italy, UK, France, and Spain, with the support of the European Community as part of its Fifth Framework Programme, Thematic Programme "Quality of Life" (contract QLG4-CT-2002-01054). The aim of DEC-net is to provide the scientific community and lay people with a flexible, free, and independent tool for disseminating clinical trial information concerning children. Methods: The DEC-net register has been implemented on a web server running the Microsoft Windows Server 2003 Standard Edition, the Internet Information Services Version 6, the Active Server Pages 2.0 web development environment, and the SQL server 7.0 DBMS. ASP language and CSS have been used to generate dynamic pages. The application is compliant with the standards supported on all popular browsers. The set of trial data to be collected fits the criteria set out by both the International Committee of Medical Journal Editors and the WHO. The main variables considered are trial identification, recruitment information, eligibility criteria, trial characteristics, study drugs, trial results, study sponsor, and location information. The ICD-9 and ATC systems have been used to classify the diseases and drugs involved and to automatically translate the terms into the language requested by the user, since the database is designed to allow access to the register in several languages. Text fields have been collected both in English and in the language of the country where the study is located (Italy, UK, Spain, and France) and the labels assigned to the coded fields and graphic elements used to compose the web pages have been translated in the four languages as well and stored in a dictionary table. Results: The register is publicly available at http://www.dec-net.org and includes more than 180 planned or ongoing trials in the four partner countries. An administrative module allows authorised users to enter, correct, and handle trial information. Data-entry is distributed across nine screens. Data checking and validation are part of the data-entry process. A modification function allows authorised users to correct data, complete missing information, or update data that may vary over time. A monitoring function can be used by the national co-ordinators to monitor overall country data-entry status. A search module allows the general public and health care professionals to search the register in several languages and in two different formats (one is suggested for professionals and includes more detailed information). The browsing module enables users to browse the register's trials using a hierarchical list of conditions involved. The resulting pages illustrating trial details are composed by extracting text fields and labels from the trial records in the appropriate language. Security tools including firewalls and passwords have been implemented to protect the register against intruders an unauthorised use. Discussion: The DEC-net register is the only paediatric, population/oriented trial register. Differently from existing registers, DEC-net can be accessed in several languages. The system's architecture is flexible and could be used to register clinical trials in other medical areas without significant modifications. DEC-net represents the beginning of a long-term project and we hope its use will be extended to other European countries.