Resumen

GARBI NOVAES, Maria Rita et al. Adverse reactions in clinical trials carried out in Brazil with new drugs. Years 2000-2012. Rev. Med. Electron. [online]. 2015, vol.37, n.1, pp. 18-29. ISSN 1684-1824.

Background: clinical trials are an experimental kind design used to assess any diagnostic and therapeutic performance applied to human beings. Aim: to assess the reports of adverse reactions to drugs, according to causality, seriousness, age and vulnerable groups in protocols of new drugs clinical trials analyzed in the Research Ethic Committee of Brasilia Health Secretariat, Federal District, Brazil. Method: cross-sectional, descriptive, observational study of case study kind. As universe of work, we took into account the projects assessed by the Research Ethic Committee of Brasilia Health Secretariat, Federal District (CEI/SES/DF in Portuguese) in the period from 2000 to 2012. Outcomes: 59 % of the research corresponded to national studies and 41 % to international ones. The pharmaceutical industry was the financeable source in 65 % of the cases and there it was foreign participation in 41 % of them. 19 % of the studied drugs were not registered in the National Agency of Sanitary Surveillance (ANVISA in Portuguese) and control group was used in only 9.5 % of the trials. The adverse reactions were considered as related to drugs, possible or improbable in 15.7 %, 19.8 % and 63.6 %, respectively. Conclusions: most of the research where new drugs were assessed was carried out by Brazilian institutions and most of them received international financial support. The lack of registration of several new products in the national regulatory agency and not using control groups were limitations identified during the assessing process in several clinical trials. We identified the inexistence of unique models legally validated for the evaluation of adverse events to drugs.

Palabras clave : ethics in research; clinical trials; new drugs.

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