Literature DB >> 22285461

Trial registration in Latin America and the Caribbean's: study of randomized trials published in 2010.

Ludovic Reveiz1, Xavier Bonfill, Demian Glujovsky, Carlos E Pinzon, Claudia Asenjo-Lobos, Marcela Cortes, Martin Canon, Ariel Bardach, Daniel Comandé, Andrés F Cardona.   

Abstract

OBJECTIVE: To determine the prevalence of trial registration in randomized controlled trials (RCTs) published in 2010 (PUBMED/LILACS) from Latin America and the Caribbean's (LAC) and to compare methodological characteristics between registered and nonregistered RCTs. STUDY DESIGN AND
SETTING: A search for detecting RCTs in which at least the first/contact author had a LAC's affiliation was made. We determined if RCTs were registered in the International Clinical Trial Registry Platform (ICTRP). Data were independently extracted by two authors. The risk of bias (RoB) was assessed in all registered RCTs (n=89) and in a sample of nonregistered RCTs (n=237).
RESULTS: The search identified 1,695 references; 526 RCTs from 19 countries were included. 16.9% (89/526) of RCTs were registered in the ICTRP; however, only 21 (4.0%) were prospectively registered. A significant difference was found in the overall assessment of the RoB between registered and nonregistered RCTs. Overall, registered RCTs were multinational, had larger sample size and longer follow-up, and reported more frequently information on funding, conflict of interests, and ethic issues. No significant differences were found when analyzing prospectively registered RCTs.
CONCLUSION: This study shows that trial registration rates are still low in LAC and the quality of reporting needs to be improved. Copyright Â
© 2012 Elsevier Inc. All rights reserved.

Mesh:

Year:  2012        PMID: 22285461     DOI: 10.1016/j.jclinepi.2011.09.003

Source DB:  PubMed          Journal:  J Clin Epidemiol        ISSN: 0895-4356            Impact factor:   6.437


  11 in total

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Review 2.  Characteristics of randomized trials published in Latin America and the Caribbean according to funding source.

Authors:  Ludovic Reveiz; Stephanie Sangalang; Demian Glujovsky; Carlos E Pinzon; Claudia Asenjo Lobos; Marcela Cortes; Martin Cañón; Ariel Bardach; Xavier Bonfill
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9.  The quality of registration of clinical trials: still a problem.

Authors:  Roderik F Viergever; Ghassan Karam; Andreas Reis; Davina Ghersi
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10.  Prospective registration and reporting of trial number in randomised clinical trials: global cross sectional study of the adoption of ICMJE and Declaration of Helsinki recommendations.

Authors:  Mustafa Al-Durra; Robert P Nolan; Emily Seto; Joseph A Cafazzo
Journal:  BMJ       Date:  2020-04-14
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