Non-commercial vs. commercial clinical trials: a retrospective study of the applications submitted to a research ethics committee.
Br J Clin Pharmacol
; 84(6): 1384-1388, 2018 06.
Article
em En
| MEDLINE
| ID: mdl-29446851
ABSTRACT
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.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
/
Apoio à Pesquisa como Assunto
/
Ensaios Clínicos Controlados como Assunto
/
Comitês de Ética em Pesquisa
/
Indústria Farmacêutica
Tipo de estudo:
Observational_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2018
Tipo de documento:
Article