Article type
Year
Abstract
Background: Trial registration is a prerequisite for publication of studies in respected scientific journals. Recent Brazilian regulations also require the registration of some clinical trials in the national registry (ReBEC), but there is little information available about practical questions involved in the registration process.
Objectives: To discuss the importance of trial registration and practical issues involved in this process.
Methods: Information was obtained from trial registry platforms, reference lists, and websites (last search: September, 2014) on the following topics: definition of a trial, history, purpose and importance of trial registries, which information should be registered and the process of registration.
Results: Clinical trial registration aims to avoid publication bias. In Brazil, it is required by journals indexed in LILACS, SciELO; worldwide it is required by ICMJE-affiliated journals. Recent Brazilian laws require that all trials (phases I to IV) involving new drugs to be marketed in the country must be registered in the Brazilian Clinical Trials Registry (ReBEC). The pros and cons of using different trial registration platforms are discussed in an article accepted by the Sao Paulo Medical Journal.
Conclusions: Trial registration is important and currently there are mechanisms to enforce its implementation. Researchers should take into account national laws and publication requirements when choosing the platform on which they will register their trial.
Objectives: To discuss the importance of trial registration and practical issues involved in this process.
Methods: Information was obtained from trial registry platforms, reference lists, and websites (last search: September, 2014) on the following topics: definition of a trial, history, purpose and importance of trial registries, which information should be registered and the process of registration.
Results: Clinical trial registration aims to avoid publication bias. In Brazil, it is required by journals indexed in LILACS, SciELO; worldwide it is required by ICMJE-affiliated journals. Recent Brazilian laws require that all trials (phases I to IV) involving new drugs to be marketed in the country must be registered in the Brazilian Clinical Trials Registry (ReBEC). The pros and cons of using different trial registration platforms are discussed in an article accepted by the Sao Paulo Medical Journal.
Conclusions: Trial registration is important and currently there are mechanisms to enforce its implementation. Researchers should take into account national laws and publication requirements when choosing the platform on which they will register their trial.