Abstract
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 that there is a mismatch between the research interests of foreign sponsors and those of the Ministry of Health, and describes some of the weaknesses in the ethical evaluation of clinical trial protocols; then it advances solutions.
Brazil has pioneered an effort to limit the use of placebo-controlled trials in developing countries when an alternative treatment is available, and to guarantee that research participants have access to the most effective treatment. The values underlying this initiative and the role of the Brazilian Medical Association during the last revision of the Declaration of Helsinki at the World Medical Assembly are reported here.
The chapter ends with an analysis of the remaining challenges to ensure that clinical research responds to the needs of the Brazilian population and is conducted in a manner that respects the rights of the participants and the integrity of the scientific process.
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de Freitas, C.B.D., Schlemper, B.R. (2014). Progress and Challenges of Clinical Research with New Medications in Brazil. In: Homedes, N., Ugalde, A. (eds) Clinical Trials in Latin America: Where Ethics and Business Clash. Research Ethics Forum, vol 2. Springer, Cham. https://doi.org/10.1007/978-3-319-01363-3_7
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