title: Prospective registration and results disclosure of clinical trials in the Americas: a roadmap toward transparency.
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.
authors.affiliation: Canadian Institutes of Health Research, Ottawa, Ontario, Canada. karmela.krleza-jeric@cihr-irsc.gc.ca
authors.forename: Karmela
authors.initials: K
authors.lastname: Krleža-Jeriç
authors.forename: Trudo
authors.initials: T
authors.lastname: Lemmens
authors.forename: Ludovic
authors.initials: L
authors.lastname: Reveiz
authors.forename: Luis Gabriel
authors.initials: LG
authors.lastname: Cuervo
authors.forename: Lisa Anne
authors.initials: LA
authors.lastname: Bero
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000569:Americas; D002986:Clinical Trials as Topic / Q000941:ethics / Q000379:methods* / Q000592:standards; D003625:Data Collection; D030881:Disclosure / Q000941:ethics / Q000592:standards; D057286:Electronic Health Records; D006801:Humans; D033181:Information Dissemination / Q000941:ethics; D007258:Informed Consent; D007391:International Cooperation; D015337:Multicenter Studies as Topic / Q000941:ethics / Q000379:methods / Q000592:standards; D018579:Patient Selection; D012107:Research Design / Q000592:standards; D016896:Treatment Outcome; D014342:Truth Disclosure; D014944:World Health Organization