Comparative analysis of policies regulating clinical trials Análise comparativa de políticas de regulamentação de ensaios clínicos Análisis comparativo de las políticas de reglamentación de los ensayos clínicos

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dc.contributor.authorBataglia W.
dc.contributor.authorAlves F.S.
dc.contributor.authorDe-Carli E.
dc.date.accessioned2024-03-12T23:50:17Z
dc.date.available2024-03-12T23:50:17Z
dc.date.issued2020
dc.description.abstract© 2020 Pan American Health Organization. All rights reserved.The present article compares clinical trial regulations in Brazil, India, Canada, and the European Union with the aim of providing evidence for an evaluation of the Brazilian regulatory policy. For that, a document analysis approach was used, in four steps: preliminary exploratory analysis; descriptive study; categorization of information; contrasting contents. Noteworthy differences between the Brazilian regulatory framework as compared to the other regions studied include the existence of several laws and regulations in Brazil vs. a single rule in the other countries; the absence of requirements regarding drug traceability and collection and disposal of unused drugs if a study is interrupted or cancelled; and a higher time of 180 days for approval of clinical trials (vs. 30 days in the European Union or Canada, for example). This suggests opportunities for improvement and update of the Brazilian regulations vis-à-vis the international scenario.
dc.description.volume44
dc.identifier.doi10.26633/RPSP.2020.3
dc.identifier.issn1680-5348
dc.identifier.urihttps://dspace.mackenzie.br/handle/10899/35111
dc.relation.ispartofRevista Panamericana de Salud Publica/Pan American Journal of Public Health
dc.rightsAcesso Aberto
dc.subject.otherlanguageBrazil
dc.subject.otherlanguageClinical trial
dc.subject.otherlanguageDrug
dc.subject.otherlanguageHealth policy
dc.subject.otherlanguageInnovation
dc.subject.otherlanguageLegislation
dc.titleComparative analysis of policies regulating clinical trials Análise comparativa de políticas de regulamentação de ensaios clínicos Análisis comparativo de las políticas de reglamentación de los ensayos clínicos
dc.typeArtigo
local.scopus.citations0
local.scopus.eid2-s2.0-85083918746
local.scopus.updated2024-05-01
local.scopus.urlhttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85083918746&origin=inward
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