Methodology Components

Clinical Trials Registry

Registry of Clinical Trials: BIREME announces that journals in LILACS and SciELO should follow the WHO orientations

The debate concerning transparency of clinical trials began several years ago, peaking in 2005, when the World Health Organization (WHO) defined a policy for their public registry (read full article here), which is supported by the International Committee of Medical Journal Editors (ICMJE) and the World Association of Medical Editors (WAME).

The WHO points out the importance of these registers as sources of evidence of efficacy and safety of interventions in health. Their public registry is crucial to ensure transparency in their execution and publication of results, and to comply with ethical responsibilities.

The BIREME/PAHO/WHO participated in the discussions regarding this policy, which took place at the Workshop ICTPR: strategies to promote adherence to the International Clinical Trials Registry platform in Latin America & the Caribbean”, during the 8th Brazilian Congress of Collective Health and the 11th World Congress of Public Health, held in the city of Rio de Janeiro, Brazil, in August 2006.

Understanding the importance of these initiatives, so that journals from Latin America and the Caribbean follow recommendations and international quality standards, this week BIREME is launching a recommendation to health-related scientific journal editors indexed at the Scientific Library Electronic Online (SciELO) and LILACS (Latin American and Caribbean Literature on Health Sciences).

According to the WHO, the randomized controlled trials and Clinical Trials should be notified and registered before they begin. This will enable identifying all ongoing clinical trials and their respective results, since not all of them are published in scientific articles. The International Committee of Medical Journal Editors (ICMJE) suggests that scientific journal editors should require the registry number from the authors when they submit articles (access text here). The text suggested in BIREME recommendation, which follows ICMJE proposal, should be included in the Instructions for Authors.

Likewise the MEDLINE database, specific fields were included in LILACS and SciELO to enter the clinical trial registry number for articles published in health journals. By the end of 2007, it is expected that all scientific journals in LILACS and SciELO that publish articles on clinical trials have adhered to this policy, which will be a requirement to include and maintain the journals indexed in those sources of information. This policy will be extended to all sources of information at the Virtual Health Library (VHL).

The registry of clinical trials can be done in one of the Clinical Trial Registers, validated by the WHO and the ICMJE, and the addresses are available at the ICMJE site (access here). In order to be validated, the Clinical Trial Registers must adopt a set of criteria established by the WHO.

Latin America and the Caribbean countries have already started discussions to establish the Clinical Trial Registers, both at national and regional levels. In the future BIREME will promote access to the clinical trial registries within the VHL context, at national and regional levels, and according to the WHO orientations. The most advanced initiative in the region is the Registro Latinoamericano de Ensayos Clínicos en Curso (LatinREC) [Latin American Registry of Ongoing Clinical Trials], created with the support of the Iberian American Cochrane Collaboration. The LatinREC Portal allows registry of clinical trials conducted in Spanish-speaking Latin American countries; however, there is no search interface available yet. Some institutions from Argentina, Chile, Colombia, Costa Rica, Cuba, Ecuador, Guatemala, Mexico, Peru and Venezuela are included in the list of collaborators for this Registry.

Articles on clinical trial registry initiatives were published in the Pan American Journal of Public Health, volume 19, number 6, of June 2006 at SciELO and WHO. Read also article published in Newsletter VHL no. 59, of September 1st, 2006.

Access the document of the recommendation for editors indexed in LILACS and SciELO about registration of clinical trials

Access the list of journals in accordance with the Clinical Trials recommendations

Read more

Source: VHL Newsletter, São Paulo, May 5th, 2007. Available in: http://espacio.bvsalud.org/boletim.php?&lang=pt&style=search&articleId=05100457200752. Accessed on September 26, 2008.

BIREME - OPAS - OMS
Latin-American and Caribbean Center on Health Sciences Information
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