Progress and Challenges of Clinical Research with New Medications in Brazil
More clinical trials with pharmaceuticals are implemented in Brazil than in any other Latin American country. This chapter presents the characteristics of the Brazilian research context that render it attractive for the pharmaceutical industry, posits tha
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Progress and Challenges of Clinical Research with New Medications in Brazil Corina Bontempo Duca de Freitas and Bruno R. Schlemper Jr.
7.1
The Current Situation of Clinical Research in Brazil
More clinical trials of new medications are carried out in Brazil than in any other Latin American country. According to Clinicaltrials.gov, 1,397 clinical trials had been registered prior to April, 2010; eight before the year 2000, 1,316 between 2000 and 2009, and 73 during the first 4 months of 2010. In April, 2010, 429 studies (31 % of those registered) were recruiting participants. Most clinical trials in Brazil (922, or 71 %) are sponsored totally or in part by the pharmaceutical industry, while the remainder (29 %) are sponsored by a variety of organizations. An unknown number of the latter group includes clinical trials subcontracted by the industry to intermediary companies, such as Contract Research Organizations (CROs) and universities. Approximately 4.4 % of trials are sponsored by United States federal government agencies, including the National Institutes of Health (NIH). More than half of the registered studies are phase III trials (758), followed by phase II (268), phase IV (218), and phase I (68) (Freitas et al. 2005). As shown in Table 7.1, the number of clinical trials carried out in Brazil has increased greatly, especially between 2007 and 2008. Phase III studies predominate, but phases I and II studies have also increased. The proportion of placebo controlled studies, although high, has been decreasing. The decline in the use of placebos can be attributed, at least partly, to the leadership of Brazilian bioethicists who have been advocating for prohibiting placebo-controlled trials when alternative therapies are available. Table 7.1 presents the change that has taken place in clinical trial sponsorship. There has been a decrease in clinical trials financed by USA federal agencies, C.B.D. de Freitas (*) Coordenac¸a˜o de Pesquisa e Comunicac¸a˜o Cientı´fica, Fundac¸a˜o de Ensino e Pesquisa em Cieˆncias da Sau´de – FEPECS, Brasilia, Brazil e-mail: [email protected] B.R. Schlemper Jr. Medical School, University of West of Santa Catarina, Floriano´polis, Brazil N. Homedes and A. Ugalde (eds.), Clinical Trials in Latin America: Where Ethics and Business Clash, Research Ethics Forum 2, DOI 10.1007/978-3-319-01363-3_7, © Springer International Publishing Switzerland 2014
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Table 7.1 Clinical trials in Brazil, 2000–2010 2005 2006 2007 2008 2009 Number of registered clinical trials 173 206 203 316 294 Phase I 8 8 11 8 20 Phase II 40 45 41 61 45 Phase III 106 138 100 158 138 Phase IV 23 21 39 61 43 Sponsored by: Pharmaceutical industry 151 177 152 217 161 NIH and other USA federal agencies 13 8 7 3 4 Universities/Organizations 14 31 56 109 139 With placebo (in the title) 69 77 83 96 85 Percent of total 40 37 41 30 29 Studies in children (
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