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Although the need to register clinical trails in a publicly accessible register has been considered for years,1,2 it has only recently become a major issue. After the much-publicized situation regarding withheld data on the use of selective serotonin reuptake inhibitors in children, various groups, including the International Committee of Medical Journal Editors (ICMJE),3 have acted to increase awareness of the need for trial registration and to put pressure on pharmaceutical companies to register all trials.
Although a single, all-inclusive, worldwide register would be optimal, disciplines such as pediatrics need special attention. The well-known difficulties of conducting studies in young patients, along with the limited economic returns to pharmaceutical companies for pediatric drugs, have led to a scarcity of pediatric studies and therefore a scarcity of knowledge about drug safety and efficacy in children. The lack of scientifically evaluated medicines for children has been recognized as an area that requires correction.4,5 Legislation to increase the number of clinical trials for children has been introduced in the United States6 and is planned for Europe. To facilitate pediatric research, promote more network-based studies and identify areas where research is needed, an international register of clinical trials of drugs in children (both planned and under way) has been established, the DEC-net (Drug Evaluation in Children) register (www.dec-net.org).
Researchers, health professionals, sponsoring agencies and the public will be able to search DEC-net for information on trials specific to children. The register, supported by the European Union and currently operating as a 3-year feasibility study, was activated in 2004 and is run by groups of researchers from 4 countries: Italy, France, Spain and the United Kingdom.7 It fits the criteria outlined by the ICMJE,3 is available free of charge, allows for data correction and updating, and is designed for use by the general public as well as health care professionals. The DEC-net register is the only pediatric, population-oriented trial register set up to receive information from a variety of sources (ethics committees, national health agencies, universities, national and international medical societies, hospitals, physicians, industry and spontaneous reporters). The register complies with the criteria of the metaRegister of Controlled Trials (an international register of registers run by Current Controlled Trials; see http://controlled-trials.com/mrct), to allow future collaboration.
We agree with the ICMJE that clinical trial registers will be most useful if they are designed to include all possible trials from any country in the world. For pediatric research, the DEC-net register meets this goal.