About this project

The OpenTrials platform

OpenTrials was designed as a multilingual application suitable to any country or region willing to operate a clinical trials registry.

In Latin America and the Caribbean, national and regional instances of this platform are under consideration, under the supervision of PAHO/WHO, following the distributed model proven by the VHL network (Virtual Health Library). The first instance of OpenTrials operates in Brazil since December, 2010 (see below).

As free, Open Source software (FOSS), OpentTrials is available for download, use and customization by any country or region, as well as research institutions, industry and NGOs, independent of any prior authorization or formality. OpenTrials instances will be capable of interoperating with other registries, allowing the exchange of records following the standards set by the International Clinical Trials Registry Platform of the World Health Organization - ICTRP/WHO.

The development of OpenTrials is happening in a trasparent and open way in the RedDes portal (this site). PAHO, the Brazilian Ministry of Health, Fiocruz and BIREME have contributed to the design and implementation of OpenTrials.

ReBEC, the Brazilian Clinical Trials Registry (www.ensaiosclinicos.gov.br)

The first concrete result of this project is ReBEC - Registro Brasileiro de Ensaios Clínicos (Brazilian Clinical Trials Registry), located at http://www.ensaiosclinicos.gov.br. This first OpenTrials instance was opened to the public on December 16th, 2010, and is operated by Fiocruz (hosted by BIREME until mid-2011, thereafter fully under the responsability of Fiocruz).

As of February 2011, ReBEC is taking the necessary steps to become an ICTRP/WHO primary registry, under the guidance of the ICTRP team. When integrated to the ICTRP platform, trial records submitted and approved by ReBEC will be automatically published in the global ICTRP search portal.