Literature DB >> 22159656

Prospective registration and results disclosure of clinical trials in the Americas: a roadmap toward transparency.

Karmela Krleža-Jeriç1, Trudo Lemmens, Ludovic Reveiz, Luis Gabriel Cuervo, Lisa Anne Bero.   

Abstract

The objective of this article is to propose a roadmap toward transparency of clinical trials in the Americas by their prospective registration and results disclosure. This will broaden access to more complete and accurate data and facilitate evidence-informed decision-making and participation in research. Consequently, it should have a positive impact on people's health and should promote trust in health research. Existing initiatives were identified, registration of trials was analyzed following the World Health Organization (WHO) standards on trial registration, and a roadmap is proposed to address the gaps in advancing transparency. The analysis shows that, in spite of numerous regional and country initiatives, clinical trials taking place in nonEnglish-speaking parts of the Americas are underregistered. A roadmap is proposed to enhance research governance and good research practice by improving the transparency of clinical trials. The proposed roadmap includes strategies for implementing WHO international standards for trial registration, for developing international standards of public disclosure of trial results, and for a potential role of the Pan American Health Organization.

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Year:  2011        PMID: 22159656

Source DB:  PubMed          Journal:  Rev Panam Salud Publica        ISSN: 1020-4989


  7 in total

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Journal:  BMC Health Serv Res       Date:  2014-11-13       Impact factor: 2.655

Review 2.  IMPACT Observatory: tracking the evolution of clinical trial data sharing and research integrity.

Authors:  Karmela Krleža-Jerić; Mirko Gabelica; Rita Banzi; Marina Krnić Martinić; Bibiana Pulido; Mersiha Mahmić-Kaknjo; Ludovic Reveiz; Josip Šimić; Ana Utrobičić; Irena Hrgović
Journal:  Biochem Med (Zagreb)       Date:  2016-10-15       Impact factor: 2.313

3.  Adherence to clinical trial registration in countries of Latin America and the Caribbean, 2015.

Authors:  Pilar García-Vello; Emma Smith; Vanessa Elias; Carlos Florez-Pinzon; Ludovic Reveiz
Journal:  Rev Panam Salud Publica       Date:  2018-03-16

4.  Progress in trial registration in Latin America and the Caribbean, 2007-2013.

Authors:  Pablo Rodríguez-Feria; Luis Gabriel Cuervo
Journal:  Rev Panam Salud Publica       Date:  2017-03-23

5.  [Risk of Publication Bias in Therapeutic Interventions for COVID-19Risco de viés de publicação em intervenções terapêuticas para a COVID-19].

Authors:  Santiago Hasdeu; Fernando Tortosa
Journal:  Rev Panam Salud Publica       Date:  2021-12-16

6.  The quality of registration of clinical trials: still a problem.

Authors:  Roderik F Viergever; Ghassan Karam; Andreas Reis; Davina Ghersi
Journal:  PLoS One       Date:  2014-01-10       Impact factor: 3.240

7.  Clinical trial transparency in the Americas: the need to coordinate regulatory spheres.

Authors:  Trudo Lemmens; Carlos Herrera Vacaflor
Journal:  BMJ       Date:  2018-07-16
  7 in total

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