Practical and conceptual issues of clinical trial registration for Brazilian researchers

Authors

  • Carolina Gomes Freitas Universidade Federal de São Paulo
  • Thomas Fernando Coelho Pesavento Universidade Federal de São Paulo
  • Maurício Reis Pedrosa Universidade Federal de São Paulo
  • Rachel Riera Universidade Federal de São Paulo
  • Maria Regina Torloni Universidade Federal de São Paulo

Keywords:

Clinical trials as topic, Database [publication type], Information systems, Publication bias, Brazil

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 reg- istration 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 São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and web- sites (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 in- dexed 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 implementa- tion 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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Author Biographies

Carolina Gomes Freitas, Universidade Federal de São Paulo

BPharm. Master’s Student in the Postgraduate Evidence-Based Healthcare Program, Universidade Federal de São Paulo (UNIFESP), and Research Assistant at the Brazilian Cochrane Center, São Paulo, Brazil.

Thomas Fernando Coelho Pesavento, Universidade Federal de São Paulo

PT. Physiotherapist. Master’s Student in the Postgraduate Evidence-Based Healthcare Program, Universidade Federal de São Paulo (UNIFESP), and Research Assistant at the Brazilian Cochrane Center, São Paulo, Brazil.

Maurício Reis Pedrosa, Universidade Federal de São Paulo

BSc. Biochemist. Master’s Student in the Postgraduate Evidence-Based Healthcare Program, Universidade Federal de São Paulo (UNIFESP), and Research Assistant at the Brazilian Cochrane Center, São Paulo, Brazil.

Rachel Riera, Universidade Federal de São Paulo

MD, MSc, PhD. Professor in the Postgraduate Evidence-Based Healthcare Program, Department of Evidence-Based Medicine, Universidade Federal de São Paulo, and Researcher at the Brazilian Cochrane Center, São Paulo, Brazil.

Maria Regina Torloni, Universidade Federal de São Paulo

MD, MSc, PhD. Professor in the Postgraduate Evidence-Based Healthcare Program, Department of Evidence-Based Medicine, Universidade Federal de São Paulo, Director of the Brazilian Cochrane Center, and Researcher at the Brazilian Cochrane Center, São Paulo, Brazil.

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Published

2016-02-04

How to Cite

1.
Freitas CG, Pesavento TFC, Pedrosa MR, Riera R, Torloni MR. Practical and conceptual issues of clinical trial registration for Brazilian researchers . Sao Paulo Med J [Internet]. 2016 Feb. 4 [cited 2025 Mar. 9];134(1):28-33. Available from: https://periodicosapm.emnuvens.com.br/spmj/article/view/976

Issue

Vol. 134 No. 1 (2016)

Section

Original Article

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