Pan American Journal of Public Health, Vol. 30, No. 1, pp. 87-96, 2011
10 Pages Posted: 19 Aug 2011 Last revised: 6 Feb 2014
Date Written: August 11, 2011
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 non-English-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.
Keywords: Clinical Trials as Topic, Standards, Americas
Suggested Citation: Suggested Citation
Krlezˇa-Jeriç, Karmela and Lemmens, Trudo and Reveiz, Ludovic and Cuervo, Luis Gabriel and Bero, Lisa, Prospective Registration and Results Disclosure of Clinical Trials in the Americas: A Roadmap Toward Transparency (August 11, 2011). Pan American Journal of Public Health, Vol. 30, No. 1, pp. 87-96, 2011. Available at SSRN: https://ssrn.com/abstract=1908351