Clinical trials registry advances in Latin America and the Caribbean
Clinical trials may be better used as resources to support scientific knowledge by making results – both positive and negative - available. Researchers have the ethical responsibility with the scientific community and volunteer subjects to disseminate such results.
To spread clinical trial results in the medical literature and to make results more transparent, some institutions, such as the World Health Organization (WHO) and the International Committee of Medical Journal Editors (ICMJE) have recommended and supported initiatives for notification and registry of such studies, in order to identify ongoing investigations and their respective results, considering that not all results are published in scientific articles.
In compliance with the recommendations by the WHO and the ICMJE, the Pan American Health Organization (PAHO), together with the BIREME/PAHO/WHO (Latin American and Caribbean Center on Health Sciences Information), has supported the creation of a platform of Clinical Trial Registry for Latin America and the Caribbean.
The initiative will enable establishing national registries and an integrated search portal in the records available in the region. The countries that do not have their own system could adopt the model proposed to arrange their national registry.
The proposal was presented during the 8th Brazilian Congress of Collective Health, held in Rio de Janeiro, in 2006, and was also discussed with representatives of Argentina, Chile, Cuba, Colombia and Brazil, during the 15th Cochrane Colloquium, held in Sao Paulo, in October 2007. Today, the region already has the following registries, which have not been certified by the WHO yet: the Latin American Ongoing Clinical Trial Registry (Latin-Rec), based in Colombia and coordinated by the Latin American Cochrane Collaboration and the Cuban Public Registry of Clinical Trials.
According to the Director of BIREME/PAHO/WHO, Abel Packer, the perspective is that Latin American and Caribbean would operate their national records in a regional network with many benefits, like in the successful experiences of Virtual Health Library (VHL) and SciELO (Scientific Eletronic Library Online). "It will be an essential contribution to the development of clinical research and to transparency of clinical records," he says.
Brazil will also launch its national effort, in the second semester of 2009 – the Rebrac (Brazilian Registry of Clinical Trials). So far, the Brazilian investigators have registered the clinical trials in Latin American platforms or in registries certified by the WHO, in other regions of the world.
The Rebrac involves the Department Science and Technology (Decit) of the Secretariat of Science, Technology and Strategic Inputs - Ministry of Health; the Fundação Oswaldo Cruz, the National Health Surveillance Agency (Anvisa), and the National Council of Research Ethics (Conep). These institutions cooperate with the BIREME/PAHO/WHO and the Research Area of the PAHO to develop the platform.
Other complementary initiatives have been established by the BIREME/PAHO/WHO at the VHL, such as the VHL Evidence Portal and the Cochrane Portal at the VHL. The Evidence Portal gathers, organizes and provides integrate access to sources of information on health regarding the best level of evidence, according to the methodology proposed by the Evidence-based Medicine (EBM). It also offers contents about the EBM methodology. The Cochrane Portal collection is composed of eight databases of the Cochrane Library – the Cochrane Plus Library databases, coordinated by the Iberian American Cochrane Center, which provides contents in Spanish; and the abstracts of the Cochrane systematic reviews, translated into Portuguese by the Brazilian Cochrane Centre.
According to Renato Murasaki, manager of Information Methodologies and Technologies (MTI) of the BIREME/PAHO/WHO, the plan for Brazil is to have a platform as one of the sources of information that may be retrieved at the VHL. Since the contents of the virtual library are inter-operated with the clinical trials registered at the Rebrac, the trials that have related scientific articles available at the VHL, will be inter-associated and retrieved by the same search system.Continuation >>>
Written by: BIREME/PAHO/WHO
17.12.2008
18:06:14 h
Updated by: BIREME/PAHO/WHO
22.01.2009
11:44:33 h voltar
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