Characteristics of clinical trials protocols on COVID-19 vaccines. Meta-epidemiologic study.

• Grant number: 22/09237-2
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: January 01, 2023
• End date: December 31, 2023
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Rachel Riera
• Grantee: Yuri Yokoyama do Nascimento
• Host Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil

Abstract

Since the beginning of the pandemic, there has been a growing search for the identification of effective and safe vaccines against Covid-19. To exemplify this information, only in 2021, about 8552 Covid-19 vaccine studies were indexed in the MEDLINE database, among which about 150 are clinical trials. Although the scientific community's interest in the matter is positive for the process of covid-19 vaccination knowledge construction, it is essential that studies that evaluate the effects of vaccines be well planned, conducted, and reported. These qualities are fundamental to guarantee the reliability of the results so that they can be helpful for the government decisions making to decide on health. This will be a meta-epidemiological study, in the discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (Unifesp), to investigate the main methodological characteristics of the clinical trials on Covid-19 vaccines, registered on ClinicalTrials.gov. The study's findings will contribute to the identification of methodological limitations in these studies' planning, allowing additional care and stricter to be adopted in the future.