Clinical trial registration: a statement from the International Committee of Medical Journal Editors

Pandolfini C, Rossi V, Santoro E “Mario Negri” Pharmacological Research Institute, Milan, Italy

Arnau de Bolós JM, Danés Carreras I, Fuentes Camps I, Castel Llobet JM Fundacio Institut Catala de Farmacologia, Barcelona, Spain

Jacqz-Aigrain E, Zarrabian S Hôpital Robert Debré, Paris, France

Choonara I, Sammons H, Steingo J Derbyshire Children’s Hospital, University of Nottingham, Derby, United Kingdom

In the last few months, the issue of trial registration has become one of the recurrent topics in medical journals. Although the need to register clinical trials in a publicly accessible register has been considered for years (1-4) it has only recently become a major issue. After the much publicised ordeal on the withheld data on SSRIs in children, different groups, from the American Medical Association, to individual scientific organisations, to the International Committee of Medical Journal Editors (ICMJE),(5-8) acted to increase awareness of the need for trial registration and put pressure on pharmaceutical companies to register all trials.

Although having one single, all-inclusive, worldwide register would be optimal, areas such as paediatrics need special attention. The well- known difficulties in carrying out studies in young patients, along with the limited economic returns to pharmaceutical companies for paediatric drugs, has led to a scarcity of paediatric studies and therefore of knowledge on drug safety and efficacy in children. The lack of scientifically evaluated medicines for children has been recognised as an area that requires correction.(9,10) Legislation has been introduced in the USA (11) and is planned in Europe to increase the number of clinical trials in children. In order to facilitate research in paediatric patients, promote more network-based studies, and identify areas where research is needed, an international register of planned and ongoing clinical trials on drugs in children has been established, the DEC-net register (www.dec-net.org).

The aims of DEC-net are to serve as an international database of ongoing and planned clinical trials on drugs in children where researchers, health professionals, sponsoring agencies, and the public alike can search for information on trials specific to children. The register was activated in 2004 and is run by groups of researchers from four countries, Italy, France, Spain, and the United Kingdom.(12) The DEC- net register is a three-year feasibility study supported by the European Union under its Fifth Framework Programme. It fits the criteria listed in the ICMJE statement, is free of charge, allows for data correction and updating, and is designed for use by the general public as well as by health professionals. The DEC-net register is different from ClinicalTrials.gov in that it is the only paediatric, population oriented trial register and has been set up to receive trial information from networks consisting of ethical committees, national health agencies, universities, national/international medical societies, hospitals, general practitioners, industry, and spontaneous reporters from different countries. Furthermore, the register has been designed to collect the International Standard Randomised Controlled Trial Number (ISRCTN) as well as the new EudraCT identification number. In an effort to further join forces internationally, while not losing its focus on the paediatric area, the DEC-net register was set up to comply with the criteria listed in the meta-Register of Controlled Trials, an international register of registers run by Current Controlled Trials (http://controlled-trials.com/mrct), so that future collaboration could be possible.

In Europe, the recent creation of the European Clinical Trials Database (EudraCT; http://eudract.emea.eu.int), designed to include all trials in the community, is not open to the public, but only to the competent authorities of the Member States, the European Medicines Agency and the European Commission. Therefore, although it is international, the fact that it is of very limited access will, unfortunately, keep it from being directly useful to most researchers, physicians, and the public.

The ICMJE statement, signed by 13 editors from 11 different medical journals, requires, as a condition of consideration for publication, registration in a public trial registry that meets a set of specific criteria at or before the onset of patient enrolment. ClinicalTrials.gov is mentioned as the only existing register that meets a set list of requirements, mainly: it must be accessible to the public at no charge, open to all prospective registrants and managed by a non-profit organisation, backed by a system to ensure validity of the data, and electronically searchable. It must also include a defined set of trial data. Given the importance of trial registration, as demonstrated by recent events, a momentous initiative such as that of the ICMJE should place more emphasis on the international level.

Concern about ClinicalTrials.gov has been expressed, especially by non-American researchers.(13) The BMJ, in fact, published an editorial in which they state that they support the ICMJE policy, which has the same basic goal as the one they, along with numerous other medical journals, sustained with their 1997 amnesty for unpublished trials initiative,(14) except for the endorsement of ClinicalTrials.gov, since it only offers registration to specific categories of sponsors and not to everyone. We agree with what is stated in the editorial. A register, in order to be at the basis of such an initiative, should have world-wide aims; it should be designed with the idea, and capacity, to include all possible trials from different countries.

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Conflict of Interest:

None declared