Greater Transparency for Research Involving Human Beings

Medical research involving human beings will be more accessible to society based on the OpenTrials system, initiated in Brazil with a view to being implemented in Latin America and the Caribbean and in other regions.

The system is the result of a cooperation project between Brazil’s Ministry of Health, through the Department of Science and Technology (DECIT) and the Oswaldo Cruz Foundation (FIOCRUZ), and PAHO/WHO, through BIREME/PAHO/WHO.

In this project, Brazil adopts the OpenTrials system to develop the Brazilian Registry of Clinical Trials, which was launched on December 16, 2010. The registry will facilitate the transparency and dissemination of these studies to Brazilian and foreign researchers. It will also enable people suffering from rare conditions to learn about experimental treatments and to volunteer for trials.

Technological development for OpenTrials is being led by BIREME, in coordination with the Pan American Health Organization’s unit for Promotion and Development of Health Research and the Organization’s representation in Brazil. The OpenTrials software is multilingual, free, open source, and compatible with the criteria established by WHO. The primary registry for each country, the data repository of standardized clinical trials, may be exported to the International Clinical Trials Registry Platform (ICTRP) of the World Health Organization (WHO).

PAHO/WHO, through the unit for Promotion and Development of Health Research, also intends to use OpenTrials to propose a Regional Primary Registry of Clinical Trials, in Spanish and French with translation into English, for countries without local capacity to develop their own national registries.

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