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Prospective Registration and Results Disclosure of Clinical Trials in the Americas: A Roadmap Toward Transparency

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

Karmela Krlezˇa-Jeriç

Canadian Institute for Health Information

Trudo Lemmens

University of Toronto - Faculty of Law

Ludovic Reveiz

affiliation not provided to SSRN

Luis Gabriel Cuervo

affiliation not provided to SSRN

Lisa Bero

University of California, San Francisco (UCSF) - School of Pharmacy; Institute for Health Policy Studies

Date Written: August 11, 2011

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 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

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

Karmela Krlezˇa-Jeriç

Canadian Institute for Health Information

495 Richmond Road, Suite 600
Ottawa, Ontario K2A 4H6
Canada

Trudo Lemmens (Contact Author)

University of Toronto - Faculty of Law ( email )

78 and 84 Queen's Park
Toronto, Ontario M5S 2C5
Canada

Ludovic Reveiz

affiliation not provided to SSRN

Luis Gabriel Cuervo

affiliation not provided to SSRN

Lisa Bero

Institute for Health Policy Studies ( email )

Third Avenue and Parnassus
San Francisco, CA 94143
United States
(415) 476-1067 (Phone)
(415) 502-0792 (Fax)

University of California, San Francisco (UCSF) - School of Pharmacy ( email )

Department of Clinical Pharmacy
San Francisco, CA 94143
United States
(415) 476-1067 (Phone)
(415) 502-0792 (Fax)

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