RESUMO
There are many difficulties in undertaking independent clinical research without support from the pharmaceutical industry. In this retrospective observational study, some design characteristics, the clinical trial public register and the publication rate of noncommercial clinical trials were compared to those of commercial clinical trials. A total of 809 applications of drug-evaluation clinical trials were submitted from May 2004 to May 2009 to the research ethics committee of a tertiary hospital, and 16.3% of trials were noncommercial. They were mainly phase IV, multicentre national, and unmasked controlled trials, compared to the commercial trials that were mainly phase II or III, multicentre international, and double-blind masked trials. The commercial trials were registered and published more often than noncommercial trials. More funding for noncommercial research is still needed. The results of the research, commercial or noncommercial, should be disseminated in order not to compromise either its scientific or its social value.
Assuntos
Ensaios Clínicos Controlados como Assunto/economia , Ensaios Clínicos Controlados como Assunto/métodos , Indústria Farmacêutica/economia , Comitês de Ética em Pesquisa , Projetos de Pesquisa , Apoio à Pesquisa como Assunto/economia , Ensaios Clínicos Fase II como Assunto/economia , Ensaios Clínicos Fase II como Assunto/métodos , Ensaios Clínicos Fase III como Assunto/economia , Ensaios Clínicos Fase III como Assunto/métodos , Ensaios Clínicos Fase IV como Assunto/economia , Ensaios Clínicos Fase IV como Assunto/métodos , Ensaios Clínicos Controlados como Assunto/ética , Indústria Farmacêutica/ética , Humanos , Estudos Multicêntricos como Assunto/economia , Estudos Multicêntricos como Assunto/métodos , Sistema de Registros , Apoio à Pesquisa como Assunto/ética , Estudos RetrospectivosRESUMO
CombiVacS study has demonstrated a strong immune response of the heterologous ChAdOx1-S/BNT162b2 vaccine combination. The primary outcomes of the study were to assess the humoral immune response against SARS-CoV-2, 28 days after a third dose of a mRNA vaccine, in subjects that received a previous prime-boost scheme with ChAdOx1-S/BNT162b2. Secondary outcomes extended the study to 3 and 6 months. The third vaccine dose of mRNA-1273 in naive participants previously vaccinated with ChAdOx1-S/BNT162b2 regimen reached higher neutralizing antibodies titers against the variants of concern Delta and BA.1 lineage of Omicron compared with those receiving a third dose of BNT162b2 at day 28. These differences between BNT162b2 and mRNA-1273 arms were observed against the ancestral variant G614 at day 90. Suboptimal neutralizing response was observed against BQ.1.1, XBB.1.5/XBB.1.9, and JN.1 in a relevant proportion of individuals 180 days after the third dose, even after asymptomatic Omicron breakthrough infections. EudraCT (2021-001978-37); ClinicalTrials.gov (NCT04860739).