Abstract

http://ssrn.com/abstract=1908351
 
 

References (61)



 


 



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


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

August 11, 2011

Pan American Journal of Public Health, Vol. 30, No. 1, pp. 87-96, 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.

Number of Pages in PDF File: 10

Keywords: Clinical Trials as Topic, Standards, Americas

Accepted Paper Series





Download This Paper

Date posted: August 19, 2011 ; Last revised: February 6, 2014

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: http://ssrn.com/abstract=1908351

Contact Information

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
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)
Institute for Health Policy Studies ( email )
Third Avenue and Parnassus
San Francisco, CA 94143
United States
(415) 476-1067 (Phone)
(415) 502-0792 (Fax)
Feedback to SSRN


Paper statistics
Abstract Views: 364
Downloads: 52
Download Rank: 231,660
References:  61

© 2014 Social Science Electronic Publishing, Inc. All Rights Reserved.  FAQ   Terms of Use   Privacy Policy   Copyright   Contact Us
This page was processed by apollo2 in 0.344 seconds