• Sao Paulo Med J · Jan 2016

    Practical and conceptual issues of clinical trial registration for Brazilian researchers.

    • Carolina Gomes Freitas, Thomas Fernando Coelho Pesavento, Maurício Reis Pedrosa, Rachel Riera, and Maria Regina Torloni.
    • Universidade Federal de São Paulo, São Paulo, Brazil.
    • Sao Paulo Med J. 2016 Jan 1; 134 (1): 283328-33.

    Context And ObjectiveClinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process.Design And SettingDescriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil.MethodsInformation was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process.ResultsClinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed.ConclusionsClinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

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