Profile of Clinical Trials Submitted for Ethical Review by the National Research Ethics Committee between 2015 and 2019

• Autor(a) principal: Naud, Ludmila
• Data de Publicação: 2021
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Brazilian Journal of Forensic Sciences, Medical Law and Bioethics
• Texto Completo: https://www.ipebj.com.br/bjfs/index.php/bjfs/article/view/814
• topic: Clinical trial; Bioethics; Clinical trial protocol; Research ethics committee; Ensaio Clínico; Bioética; Protocolo de Ensaio Clínico; Comitês de Ética em Pesquisa

We aim to characterize the clinical trials submitted for Conep’s ethical analysis. The protocolos were registered in Plataforma Brasil from 2015 to 2019, and to compare national and international clinical trials. In this sense, we did an exploratory and retrospective study using Plataforma Brasil with extraction of data from clinical research protocols. Only initial protocols were considered. The data were presented by frequency and relative distribution and the comparison was made in relation to protocols with origin from Brazil and overseas. 904 clinical trials were submitted for ethical analysis from phase I to IV. He number of clinical trials remained stable during the analyzed period, with a downward trend for international studies with private funding and an upward trend for national studies with public funding. There was a difference between the profile of national and international clinical trials. In despite of the growing government incentive and a slight increase in the number of national studies with public funding, there is still a huge foreign dependence, which impedes scientific development in the country. The results obtained in the present study can contribute to the debate on clinical research in Brazil.