Article type
Year
Abstract
Introduction: A proposal for comprehensive trials registration has been formally presented and supported by the International Committee of Medical Journal Editors and the Cochrane Collaboration. Recent studies have predicted that the number of clinical trials taking place in Latin-America will have doubled by 2008. 4,191 clinical-trial published by authors affiliated to institutions located in Latin-American countries have been currently indexed with Medline, representing 0.97% of all randomised clinical trials (RCT) registered in this database. Surprisingly, few of them have been prospectively included in an international clinical trial register.
Objective: Designing and implementing an electronic logical database for registering ongoing clinical trials in Latin-America. Based on the Ottawa Statement regarding trials registration, LATINREC must provide reliable information about clinical trials developed in Latin-America to the public, health providers, researchers and funding bodies using a user-friendly platform. Although commercially available trial registers provide an alternative to LATINREC, these are not always the best choice for Latin-American trials due to language limitation, restricted regional dissemination and prohibitive costs involved in prospective international registration.
Materials and methods: LATINREC allows investigators and their proxies to publish their research protocol in an abbreviated format. We have used several commercially available tools for automating the process of converting information sent by investigators into a plain format representing all expected data. Registration is done by using a relational model having a primary key representing a unique study number (USN) for each clinical-trial regarding a new drug or intervention. Such USN is designed to complement other registers. A registry editor will review each report's content. Investigators will be encouraged to keep their entries updated. Registration is free of charge and its content is freely available to the public via the Internet. Ibero-american Cochrane network from twelve countries is involved in the project.
Result and conclusion: LATINREC is an interactive database designed for dynamically including clinical trials in Latin-America and providing information concerning protocols and reports of RCT results. LATINREC is a pioneering response to the challenge of identifying ongoing and unpublished clinical trials in Latin-America and will be available at www.latinrec.org from May 2005 onwards.
Objective: Designing and implementing an electronic logical database for registering ongoing clinical trials in Latin-America. Based on the Ottawa Statement regarding trials registration, LATINREC must provide reliable information about clinical trials developed in Latin-America to the public, health providers, researchers and funding bodies using a user-friendly platform. Although commercially available trial registers provide an alternative to LATINREC, these are not always the best choice for Latin-American trials due to language limitation, restricted regional dissemination and prohibitive costs involved in prospective international registration.
Materials and methods: LATINREC allows investigators and their proxies to publish their research protocol in an abbreviated format. We have used several commercially available tools for automating the process of converting information sent by investigators into a plain format representing all expected data. Registration is done by using a relational model having a primary key representing a unique study number (USN) for each clinical-trial regarding a new drug or intervention. Such USN is designed to complement other registers. A registry editor will review each report's content. Investigators will be encouraged to keep their entries updated. Registration is free of charge and its content is freely available to the public via the Internet. Ibero-american Cochrane network from twelve countries is involved in the project.
Result and conclusion: LATINREC is an interactive database designed for dynamically including clinical trials in Latin-America and providing information concerning protocols and reports of RCT results. LATINREC is a pioneering response to the challenge of identifying ongoing and unpublished clinical trials in Latin-America and will be available at www.latinrec.org from May 2005 onwards.