Trends in research involving human beings in Brazil.
Developing countries have experienced a dramatic increase in the number of clinical studies in the last decades. The aim of this study was to describe 1) the number of clinical trials submitted to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, Anvisa) from 2007 to 2012 and the number of human-subject research projects approved by research ethics committees (RECs) and the National Research Ethics Committee (Comissão Nacional de Ética em Pesquisa, CONEP) in Brazil from 2007 to 2011 and 2) the diseases most frequently studied in Brazilian states in clinical trials approved in the country from 2009 to 2012, based on information from an Anvisa databank. Two databases were used: 1) the National Information System on Research Ethics Involving Human Beings (Sistema Nacional de Informação Sobre Ética em Pesquisa envolvendo Seres Humanos, SISNEP) and 2) Anvisa's Clinical Research Control System (Sistema de Controle de Pesquisa Clínica, SCPC). Data from the SCPC indicated an increase of 32.7% in the number of clinical trials submitted to Anvisa, and data from the SISNEP showed an increase of 69.9% in those approved by RECs and CONEP (from 18 160 in 2007 to 30 860 in 2011). Type 2 diabetes (26.0%) and breast cancer (20.5%)-related to the main causes of mortality in Brazil-were the two most frequently studied diseases. The so-called neglected diseases, such as dengue fever, were among the least studied diseases in approved clinical trials, despite their significant impact on social, economic, and health indicators in Brazil. Overall, the data indicated 1) a clear trend toward more research involving human beings in Brazil, 2) good correspondence between diseases most studied in clinical trials approved by Anvisa and the main causes of death in Brazil, and 3) a low level of attention to neglected diseases, an issue that should be considered in setting future research priorities, given their socioeconomic and health effects.
Agência Nacional de Vigilância Sanitária, Brasília, DF, Brazil.
Ricardo Eccard da
RE
Silva
Escola Superior de Ciências da Saúde, Fundação de Ensino e Pesquisa e Educação em Ciências da Saúde, Brasília, DF, Brazil.
Maria Rita Carvalho
MR
Novaes
Secretaria de Estado de Saúde do Distrito Federal, Brasília, DF, Brazil.
Elza Martínez
EM
Pastor
Faculdade de Medicina, Universidad Nacional del Comahue, Neuquén, Argentina.
Elena
E
Barragan
Faculdade de Ciências da Saúde, Universidade de Brasília, Brasília, DF, Brazil.
Angélica Amorim
AA
Amato
D001938:Brazil; D002423:Cause of Death; D002986:Clinical Trials as Topic / Q000941:ethics / Q000706:statistics & numerical data*; D016208:Databases, Factual; D003906:Developing Countries; D006801:Humans; D038622:Internationality; D015337:Multicenter Studies as Topic / Q000941:ethics / Q000706:statistics & numerical data; D058069:Neglected Diseases; D012106:Research / Q000639:trends*; D035842:Research Subjects; D012109:Research Support as Topic; D036302:Therapeutic Human Experimentation