Practical and conceptual issues of clinical trial registration for brazilian researchers

Practical and conceptual issues of clinical trial registration for brazilian researchers

Title: Practical and conceptual issues of clinical trial registration for brazilian researchers;
Aspectos práticos e conceituais do registro de ensaios clínicos para pesquisadores brasileiros
Author Freitas, Carolina Gomes Autor UNIFESP Google Scholar
Coelho Pesavento, Thomas Fernando Autor UNIFESP Google Scholar
Pedrosa, Mauricio Reis Autor UNIFESP Google Scholar
Riera, Rachel Autor UNIFESP Google Scholar
Torloni, Maria Regina Autor UNIFESP Google Scholar
Abstract CONTEXT AND OBJECTIVE: Clinical 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 SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in Sao Paulo, Brazil. METHODS: Information 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. RESULTS: Clinical 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. CONCLUSIONS: Clinical 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.
Keywords Clinical Trials As Topic
Database
Information Systems
Publication Bias
Brazil
Language English
Date 2016
Published in Sao Paulo Medical Journal. Sao paulo, v. 134, n. 1, p. 28-33, 2016.
ISSN 1516-3180 (Sherpa/Romeo, impact factor)
Publisher Associacao paulista medicina
Extent 28-33
Origin http://dx.doi.org/10.1590/1516-3180.2014.00441803
Access rights Open access Open Access
Type Article
Web of Science ID WOS:000373498400005
SciELO ID S1516-31802016000100028 (statistics in SciELO)
URI http://repositorio.unifesp.br/handle/11600/49555

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